MCKESSON TECHNOLOGIES INC.              Mar-05-2014      McKesson Anesthesia Care System – McKesson Anesthesia CareProduct Usage:  The McKesson Anesthesia Care system is a computer based system which collects; processes;and records data both through manual entry and from monitors which themselves are attached to patients; such as in the operating room environment. The system provides clinical decision support by communicating potential Adverse Drug Event alerts proactively during the pre-anesthesia evaluation and at the point-of-care. The system is generally indicated in the anesthetizing environment when the anesthesia provider decides to perform a patient assessment; to generate a paper and/or electronic record of the administration of anesthesia to a patient; and to document care. There was an occurrence where the patient case data did not match the patient data when the case was recalled in the Anesthesia Care Record (ACR) in that it included data from another case.

Phillips Respironics; Inc.                Mar-06-2014      Philips Respironics Trilogy 100; Trilogy 200; Trilogy 202 – Trilogy VentilatorsThe Respironics Trilogy 100 system provides continuous or intermittent ventilator support for the care of individuals who require mechanical ventilation. Trilogy 100 is intended for pediatric through adult patients weighing at least 5 kg (11 lbs.). The device is intended to be used in home; institution/hospital; and portable applications such as wheelchairs and gurneys; and may be used for both invasive and non-invasive ventilation. It is not intended to be used as a transport ventilator. Trilogy 200 Intended Use: The Respironics Trilogy 200 system provides continuous or intermittent ventilator support for the care of individuals who require mechanical ventilation. Trilogy 200 is intended for pediatric through adult patients weighing at least 5 kg (11 lbs.). The device is intended to be used in home; institution/hospital; and portable applications such as wheelchairs and gurneys; and may be used for both invasive and non-invasive ventilation. Trilogy 202 Intended Use: The Respironics Trilogy 202 system provides continuous or intermittent ventilator support for the care of individuals who require mechanical ventilation with or without air/oxygen blending. Trilogy 202 is intended for pediatric through adult patients weighing at least 5 kg (11 lbs.). The device is intended to be used in hospitals and institutions; and for portable applications such as wheelchairs and gurneys only when in an institutional setting. It may be used for both invasive and non-invasive ventilation. It is not intended to be used as a transport ventilator.       Internal testing revealed a potentially defective component on the power management board that could affect the function of certain Trilogy Ventilators resulting in loss of therapy to patients.

Greatbatch Medical        Mar-06-2014      Offset Cup Impactor – Greatbatch Medical; Offset Cup Impactor.The Standard Offset Cup Impactor is a reusable instrument used during acetabular replacement surgery to implant an acetabular cup. The Standard Offset Cup Impactor is provided non-sterile and must be sterilized prior to use in a surgery. The Standard Offset Cup Impactor is used to implant cups during many minimally invasive surgical approaches to Total Hip Arthroplasty ( ri-IA).    Greatbatch Medical has initiated a global Field Corrective Action for the Standard Offset Cup Impactor since the product was first released in 2004.Greatbatch has identified through internal Sterility Assurance Level validation testing that a sterility assurance level of 10-6 is not achieved on the Standard Offset Cup Impactor when it is subjected to the steam sterilization cycles and associat



Abbott Diabetes Care; Inc.           Mar-18-2014      FreeStyle Flash Blood Glucose Monitors – FreeStyle Blood Glucose Monitors System.For in vitro diagnostic use only. Store at roomtemperature below 86 degrees F (30 degrees C). Use test stripsonly within the system operating temperaturerange as outlined in your Owner’s Booklet.Meter made in China;Distributed by Abbott Diabetes Care; Alameda; CAThe FreeStyle mete should only be used with FreeStyle Test Strips and FreeStyle Control Solution. Using other brands of test strips and control solutions with the FreeStyle Mete can product inaccurate results.The FreeStyle Glucose meter is incorporated into the OmniPod insulin Management system (manufactured by Insulet Corporation; Bedford; MA and is intended for subcutaneous delivery of insulin.Intended to monitor blood glucose from samples taken from the body. IVD use only;            Abbott Diabetes Care has identified through internal testing and investigation that all non-applied voltage legacy meters have the potential to produce out of range control solution results and/or erroneously low blood glucose results when used in conjunction with Free Style test strips lots within expiry.

Abbott Diabetes Care; Inc.           Mar-18-2014      FreeStyle Flash Blood Glucose Monitors – FreeStyle  Flash  Blood Glucose Monitors System.Meter made in China;Distributed by TheraSense;  Alameda; CAThe FreeStyle Flash meter should only be used with FreeStyle Test Strips and FreeStyle Control Solution. Using other brands of test strips and control solutions with the FreeStyle Meter can product inaccurate results.Intended to monitor blood glucose from samples taken from the body. IVD use only;     Abbott Diabetes Care has identified through internal testing and investigation that all non-applied voltage legacy meters have the potential to produce out of range control solution results and/or erroneously low blood glucose results when used in conjunction with Free Style test strips lots within expiry.

Thoratec Corporation     Mar-21-2014      HeartMate II System Controller – HeartMate II System ControllerProduct Usage:  HeartMate II is a mechanical device that circulates blood throughout the body when the heart is too weak to pump blood adequately on its own. It is sometimes called a a heart pump or VAD. HeartMate II is a small implantable LVAD. HeartMate II attaches to the heart and is designed to assist or take over the pumping function of the patients left ventricle; the main pumping chamber of the heart.                Discovery of serious injuries and deaths associated with the process of changing from a primary System controller to their back-up System controller in patients using the Pocket System controller model.

Thoratec Corporation     Mar-21-2014      Heart Mate II Pocket Controllers removed from packaging – Heart Mate II Pocket Controllers removed from packagingProduct Usage:  HeartMate II is a mechanical device that circulates blood throughout the body when the heart is too weak to pump blood adequately on its own.       Discovery of serious injuries and deaths associated with the process of changing from a primary System controller to their back-up System controller in patients using the Pocket System controller model.

Thoratec Corporation     Mar-21-2014      HeartMate II LVAD Pump and Pock Controller Kit; – HeartMate II LVAD Pump and Pock Controller Kit;Product Usage:  HeartMate II is a mechanical device that circulates blood throughout the body when the heart is too weak to pump blood adequately on its own.               Discovery of serious injuries and deaths associated with the process of changing from a primary System controller to their back-up System controller in patients using the Pocket System controller model.

Thoratec Corporation     Mar-21-2014      HeartMate II Implant Kit with Pocket Controller; – HeartMate II Implant Kit with Pocket Controller;with sealed grafts (NAm)with sealed grafts (EU)Product Usage:  HeartMate II is a mechanical device that circulates blood throughout the body when the heart is too weak to pump blood adequately on its own.              Discovery of serious injuries and deaths associated with the process of changing from a primary System controller to their back-up System controller in patients using the Pocket System controller model.

Draeger Medical Systems; Inc.   Mar-28-2014      Drager PS500 Power Supply Unit of the Infinity ACS Workstation Critical Care – Drager PS500 Power Supply Unit of the Infinity ACS Workstation Critical Care (Evita Infinity V500)ventilation during short term transport of patients within a hospital             The battery capacity of the optional PS500 Power Supply Unit of the Infinity ACS Workstation Critical Care (Evita Infinity V500) did not last as long as expected.

Medical Information Technology; Inc.     Mar-03-2014      MEDITECH Microbiology – MEDITECH Microbiology – Calculator/data processing module; for clinical use.          Potential for patient results being removed from LAB/EMR.

Toshiba American Medical Systems Inc  Mar-03-2014      TSX-IOIA: Aquilion 32/64 ONE; System; X-Ray; Tomography; Computed – TSX-101A Aquilion 32/64 ONE Computed Tomography X-Ray System; TXS-101/R Aquilion RXL Computed Tomography X-Ray System; TSX-301A Aquilion One Computed Tomography X-Ray System; TSX-301B Aquilion Premium Computed Tomography X-Ray System; TSX-302A Aquilion Prime Computed Tomography X-Ray System.This device is indicated to acquire and display cross sectional volumes of the whole body; to include the head. The Aquilion RXL has the capability to provide volume sets. These volume sets can be used to perform specialized studies; using indicated software/hardware; by a trained and qualified physician.             Toshiba intitiated this recall because their investigation revealed that due to a problem of the X-ray output control software; the X-ray output conditions may not be set correctly. As a result; X-ray exposure under the scan conditions used for contrast study may not start.

AMO Puerto Rico Manufacturing; Inc.    Mar-03-2014      AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design – AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design; Model Z9002; diopter size: 16.0 and 21.0.Indicated for primary implantation for the visual correction of aphakia in adult patients.            Certain Silicone TECNIS IOLs may be labeled with the incorrect diopter power.

WalkMed Infusion; LLC  Mar-03-2014      Triton FP Infusion Pump – Triton FP Infusion Pump; Part Number 400000; packaged in boxes.The Triton Volumetric Infusion Pump is indicated for delivering infusions of medications; as well as providing TPN (Total Parenteral Nutrition) and PCA (Patient Control Analgesia). It is intended for use in hospitals; ambulatory & nursing home (extended care) settings; and home care environments. WalkMed Infusion is initiaing a recall on their Triton FP Infusion Pump; Part Number 400000 due to the label on the right side of the pump containing an incorrectinstruction.

AlterG; Incorporated      Mar-04-2014      AlterG Anti-Gravity Treadmill – Accessory shorts for the AlterG Anti-Gravity treadmill.Use with the AlterG Anti-Gravity Treadmill for rehabilitation.   Unapproved material used by vendor in subset of shorts causing them to stretch more than usual and are uncomfortable for patient.

DeRoyal Industries Inc   Mar-04-2014      DeRoyal(R) ST. Circumcision Clamp; REF 32-1622; Size 1.3 cm – DeRoyal(R) ST. Circumcision Clamp; REF 32-1622; Size 1.3 cm; 1 Per Pack;  Rx Only STERILE EO; distributed by DeRoyal Industries; 200 DeBusk Lane; Powell; TN  37849                Three lots of circumcision clamps were manufactured out of specification and as a result may not properly clamp at  the surgical site completely.

Synthes; Inc.      Mar-04-2014      Synthes 5.0mm Variable Locking Screw – Synthes 5.0mm Variable Locking ScrewThis device is part of the Variable Angle Locking Compression Plate family and this technology included variable angle Combi holes in the plate shaft.The variable angle Combi hole provides the flexibility of axial compression and variable locking capacity throughout the length of the plate shaft.             Labeling correction: The package insert in one 5.0mm Variable Locking Screw package was a GP0006 (Anterior Cervical Vertebrae Plate System) insert; which should have been a GP2848 (4.5mm VA-LCP Curved Condylar Plate System insert).

Djo Surgical         Mar-04-2014      FMP X-alt Acetabular Liner – FMP X-alt Acetabular LinerThis acetabular liner is intended for use with DJO Surgical hip systems. It is used with an acetabular shell to replicate the kinematics of a natural hip.                Packaging error — two different types and sizes of acetabular liners used during hip replacement surgery were mistakenly packaged into each other’s outer boxes after sterilization; resulting in the products being mislabeled.  The units labeled as Model/Catalog Number 931-28-248 Lot/Serial Number 685F1034 on the outside and containing Model/Catalog Number 932-36-252; Lot# 728F1089 on the inside (1

Carestream Health Inc.  Mar-04-2014      Model Kodak 2200 Intraoral X-Ray System – Model Kodak 2200 Intraoral X-Ray System; Catalog Numbers 5303177; 5303169; 5303151; XR-5154323 — Carestream Health; Inc. 150 Verona Street; Rochester; NY 14608 — Made in France — TROPHY 77435 Marne La Vallee — COMMON/USUAL NAME:  Dental X-Ray Systems — CLASSIFICATION NAME:  Unit; X-Ray; Extraoral  with timer — There are four major components:  x-ray tube; x-ray generator; collimator and image receptor. These systems are permanently installed diagnostic dental x-ray systems for generation of x-rays for examination of the teeth; jaw and oral structures.          Carestream received problem reports relating to apparent early failure of Kodak 2X00 Intraoral X-ray device arms leading to arm breakage.

Carestream Health Inc.  Mar-04-2014      Model Kodak 2100 Intraoral X-Ray System – Model Kodak 2100 Intraoral X-Ray System; Catalog Numbers 5303144; 8011579 — Carestream Health; Inc. 150 Verona Street Rochester; NY 14608 — Made in France — TROPHY 77435 Marne La Vallee — COMMON/USUAL NAME:  Dental X-Ray Systems — CLASSIFICATION NAME:  Unit; X-Ray; Extraoral  with timer — There are four major components:  x-ray tube; x-ray generator; collimator and image receptor.  These systems are permanently installed diagnostic dental x-ray systems for generation of x-rays for examination of the teeth; jaw and oral structures.           Carestream received problem reports relating to apparent early failure of Kodak 2X00 Intraoral X-ray device arms leading to arm breakage.

MEDICAMAT S.A.             Mar-04-2014      Punch Hair Matic – Punch Hair MaticA surgical hair transplant device designed for automation of follicular transplantation.                Medicamat is initiating a field correction due to misbranded marketing literature for the Punch Hair Matic SAFER.

Mako Surgical Corporation           Mar-04-2014      Restoris Multicompartmental Knee (MCK) System – Restoris Multicompartmental Knee (MCK) System is an implant system designed to be used with MAKO’s Robotic Arm Interactive Orthopedic System (RIO). It is composed of a unicompartmental implant system (Restoris MCK Uni) and a patellofemoral implant system (Restoris MCK PF). The Restoris MCK Uni is designed for use when load bearing ROM is expected to be less than or equal to 155 degrees. In Restoris MCK combination where multi-compartmental areas are being treated; the Restoris MCK components were designed with 3 mm of gap between the components to ensure that the components do not interfere.Is indicated for single or multi-compartmental knee replacement used in conjunction with RIO; in individuals with osteoarthritis or post-traumatic arthritis of the tibiofemoral and/or patellofemoral articular surfaces.            The product may be mislabeled and could result in the incorrect implant being used.

Heraeus Kulzer; LLC.       Mar-04-2014      Benco Dental Tartar & Stain Remover – BencoDental tartar & stain remover ultrasonic cleaning solutionProduct Usage:  Formulated especially for removal of calculus; tartar; tobacco and food stains from dentures; bridges; orthodontic appliances; etc. Use also for removal of permanent cement.            As the result of a complaint to Heraeus Kulzer’s customer service department; Heraues Kulzer is recalling Benco Tartar and Stain Solution part #1010-451; lot #13121434 because it has incorrect labeling on the immediate container.  While the outer carton correctly states "Benco Tartar and Stain"; the immediate gallon container in which the solution is contained incorrectly states "Benco Temporary C

Focus Diagnostics Inc      Mar-05-2014      Simplexa Flu A/B & RSV Direct assay – Simplexa Flu AlB & RSV Direct Assay Kits; intended for use as an aid in the differential diagnosis of influenza A; influenza B; and RSV viral infections in humans and is not intended to detect influenza C. Model Number MOL2650.   Focus Diagnostics initiated the recall of the certainSimplexa Flu AlB & RSV Direct assay kits due tothe potential of false positive Flu A; Flu B and RSV signals.

KCI USA; INC.     Mar-05-2014      PRE2001: Prevena Incision Management Customizable System Box – PRE2001: Prevena Incision Management Customizable System BoxProduct Usage:The Prevena Incision Management System is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudates via the application of negative pressure wound therapy.    Prevena Incisional Management System Kit/Dressing Connector – the male connector on the tubing is difficult to connect to the female connector on the Prevena canister tubing

KCI USA; INC.     Mar-05-2014      PRE2055US: Prevena Customizable Dressing 5-Pack (US-ONLY) – PRE2055US: Prevena Customizable Dressing 5-Pack (US-ONLY)Product Usage:The Prevena Incision Management System is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudates via the application of negative pressure wound therapy.  Prevena Incisional Management System Kit/Dressing Connector – the male connector on the tubing is difficult to connect to the female connector on the Prevena canister tubing

KCI USA; INC.     Mar-05-2014      PRE1055: Prevena Dressing; 5 Pack – PRE1055: Prevena Dressing; 5 PackProduct Usage:The Prevena Incision Management System is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudates via the application of negative pressure wound therapy.          Prevena Incisional Management System Kit/Dressing Connector – the male connector on the tubing is difficult to connect to the female connector on the Prevena canister tubing

KCI USA; INC.     Mar-05-2014      PRE1055US: Prevena Dressing; 5 Pack (US-ONLY) – PRE1055US: Prevena Dressing; 5 Pack (US-ONLY)Product Usage:The Prevena Incision Management System is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudates via the application of negative pressure wound therapy.           Prevena Incisional Management System Kit/Dressing Connector – the male connector on the tubing is difficult to connect to the female connector on the Prevena canister tubing

KCI USA; INC.     Mar-05-2014      PRE1001US:  Prevena Peel and Place System Kit (US-ONLY) – PRE1001US:  Prevena Peel and Place System Kit (US-ONLY)Product Usage:  The Prevena Incision Management System is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudates via the application of negative pressure wound therapy.  Prevena Incisional Management System Kit/Dressing Connector – the male connector on the tubing is difficult to connect to the female connector on the Prevena canister tubing

KCI USA; INC.     Mar-05-2014      PRE2055: Prevena Customizable Dressing 5-Pack – PRE2055: Prevena Customizable Dressing 5-PackProduct Usage:The Prevena Incision Management System is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudates via the application of negative pressure wound therapy.           Prevena Incisional Management System Kit/Dressing Connector – the male connector on the tubing is difficult to connect to the female connector on the Prevena canister tubing

KCI USA; INC.     Mar-05-2014      PRE2001US: Prevena Incision Management Customizable System Box (US-ONLY) – PRE2001US: Prevena Incision Management Customizable System Box (US-ONLY)Product Usage:The Prevena Incision Management System is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudates via the application of negative pressure wound therapy.               Prevena Incisional Management System Kit/Dressing Connector – the male connector on the tubing is difficult to connect to the female connector on the Prevena canister tubing

KCI USA; INC.     Mar-05-2014      PRE1001:  Prevena Peel and Place System Kit – PRE1001:  Prevena Peel and Place System KitProduct Usage:  The Prevena Incision Management System is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudates via the application of negative pressure wound therapy.     Prevena Incisional Management System Kit/Dressing Connector – the male connector on the tubing is difficult to connect to the female connector on the Prevena canister tubing

Horiba Instruments; Inc dba Horiba Medical        Mar-05-2014      ABX PENTRA Multical. ABX PENTRA N Control ABX PENTRA P Control – ABX PENTRA Multical.ABX PENTRA N Control.ABX PENTRA P Control.The ABX PENTRA 400 and PC200 are benchtop clinical chemistry analyzers using twomeasuring principals: absorbance and ion selective electrodes.The ABX PENTRA Multical is a lyophilized human serum calibrator with chemicaladditives and materials of biological origin. The assigned values of the calibratorcomponents are given in the enclosed annex; ensuring optimal calibration of theappropriate HORIBA ABX SAS methods on the ABX PENTRA Clinical ChemistryAnalyzer. This calibrator is provided in ten vials of 3 ml.                HORIBA Medical is informing all ABX PENTRA MultiCal; N Control; and P Control customers running theCreatinine Rate Blank Method assay on the ABX PENTRA 400 and PC200 that the Target Values for Creatinine RateBlank Method have been updated. This issue is only applicable to Creatinine Rate Blank Method values reported on theABX PENTRA 400 and PC200 Chemistry Analyzers only. No other analyzers

Elekta; Inc.          Mar-06-2014      Desktop Pro TM and Desktop Pro (VMAT) – Desktop Pro TM linear accelerator control software intended to assist a licensed practitioner in the delivery of radiation to defined target volumes.             During the treatment table; gantry; and collimator calibration procedures; it is possible to type incorrect values or invert a value.

GE Healthcare; LLC          Mar-06-2014      GSI Viewer – GE Healthcare; Model Number/ Description:5342114 GSI Viewer 1.10 on AW VolumeShare 4 (AW 4.5); 5342114-2 GSI Viewer 1.10 on AW VolumeShare 4 (AW 4.5); 5342114-3 GSI Viewer 1.10 on AW VolumeShare 4 (AW 4.5); 5342114-4 GSI Viewer 1.11 on AW VolumeShare 4 (AW 4.5); 5401757 GSI Viewer 1.20 on AW VolumeShare 3 (AW4.4).Computed Tomography X-Ray system When performing a secondary capture generated from GSI Viewer; the header information is correcton the images. However; when changing the ROI (region of interest) and zooming in; the DICOMheader does not change to reflect the new image; thus the line measurements may be inaccurate.

GE Healthcare; LLC          Mar-06-2014      GE Healthcare Solar 8000M and Solar 8000i Patient Monitor software version 5.4; 5.5; or 5.6 – GE Healthcare Solar 8000M and Solar 8000i Patient Monitor software version 5.4; 5.5; or 5.6 with the Automatic-View-On- Alarm (AVOA) feature enabled.The Solar 8000i with Patient Data Module / Transport Pro with Patient Data Module is intended for use under the direct supervision of a licensed healthcare practitioner; or by personnel trained in proper use of the equipment in a professional medical facility; such as hospital; clinic; surgical center or doctor’s office. It can be used in multiple areas such as operating room (OR); post anesthesia care unit (PACU); emergency department (ED); chest pain clinic; general intensive care unit (ICU); critical care unit; surgical intensive care unit (SICU); respiratory intensive care unit; coronary care unit (CCU); medical intensive care unit (MICUI; pediatric intensive care unit (PICU); or neonatal intensive care unit (NICU). The Patient Data Module (PDM) is intended to provide uninterrupted acquisition of physiologic parameter data on adult; pediatric and neonatal patients during non-transport/bedside and transport patient care episodes. Physiological parameter data acquired by the PDM includes ECG; invasive pressure; non-invasive blood pressure; pulse oximetry; temperature; cardiac output and respiration. This device acquires; processes and stores information for all aforementioned parameters and transmits this information to a transport or bedside central processing unit for viewing and alarm surveillance purposes. The Transport Pro patient monitor is intended for use as part of a transport monitoring system for intra-healthcare facility transport. When used with the Patient Data Module (PDM) or the TRAM acquisition module; this device is intended to provide uninterrupted monitoring of physiologic parameter data for adult; pediatric; and neonatal patients during transport from one area of the healthcare facility to another. Physiological parameter data includes ECG; invasive pressure; noninvasive blood pressure; pulse oximetry; temperature and respiration. Both the PDM and TRAM acquisition module acquire; process and store information for all aforementioned parameters. The Solar 8000i patient monitoring system is a multi-parameter physiological patient monitoring system intended for use on adult; pediatric and neonatal patients. It provides uninterrupted monitoring of physiological patient data. The Solar 8000i patient monitoring system is capable of monitoring and analyzing the following parameters for all patient populations: electrocardiogram; invasive pressure; non-invasive blood pressure; pulse; temperature; cardiac output; respiration; pulse oximetry; venous oxygen saturation; transcutaneous pO2 and pCO2; C02 and respiratory mechanics. The Solar 8000i patient monitoring system is capable of monitoring the following parameters for adult and pediatric patient populations: anesthetic agent concentrations; 02; impedance cardiography; electroencephalography and bispectral index. The Solar 8000i patient monitoring system interfaces with a variety of third-party peripheral medical devices that support serial and/or analog data outputs. Information from these devices can be displayed; trended and stored in the monitoring system. The Solar 8000i patient monitoring system also provides physiological data over the UNITY NETWORK TM.           GE Healthcare has recently become aware of a potential safety issue with the Solar 8000M/i Patient Monitor Automatic-View-On-Alarm (AVOA) feature.The Solar 8000M/i AVOA feature will stop functioning if the patient monitor is discharged from the CIC Central Station while a remote automatic bedside alarm view is currently being displayed on the Solar. Once this issue occurs; subsequent remote AV

Elekta; Inc.          Mar-06-2014      Multilead Collimator – Agility.Version 3.0 of the Integrity interface and control software for the Elekta range of medical digital linear accelerators which is associated with Agility collimators.               During the treatment table; gantry; and collimator calibration procedures; it is possible to type incorrect values or invert a value.

Elekta; Inc.          Mar-06-2014      Multilead Collimator – Agility.Version 3.1 of the Integrity interface and control software for the Elekta range of medical digital linear accelerators which is associated with Agility collimators.               During the treatment table; gantry; and collimator calibration procedures; it is possible to type incorrect values or invert a value.

Elekta; Inc.          Mar-06-2014      Integrity – Integrity.Version 1.1 of the Integrity interface and control software for the Elekta range of medical digital linear accelerators.          During the treatment table; gantry; and collimator calibration procedures; it is possible to type incorrect values or invert a value.

Hospira Inc.        Mar-06-2014      LifeShield Latex-Free HEMA Y-Type Blood Set IV Administration Set – *** 1) List number 126970465 labeled in part: 12697-65 LifeShield LATEX-FREE HEMA; Y-TYPE BLOOD SET; Nonvented; 88 Inch with 210 Micron Filter Pump; Prepierced Injection Site and Secure Lock; Made in Costa Rica; Product Inquiries should be directed to Hospira; Inc.; Lake Forest; IL 60045 USA; *** 2) List Number 127200465 labeled in part: 12720-65 LifeShield LATEX-FREE HEMA; BLOOD SET; Nonvented; 81 Inch with 170 Micron Filter; Pump; Prepierced Injection Site and Secure Lock; Made in Costa Rica; Product Inquiries should be directed to Hospira; Inc.; Lake Forest; IL 60045 USA; *** 3) List Number 046419701 labeled in part: Hospira VENISYSTEMS Blood Bottle Pump Set with CAIR ClampHospira infusion blood sets are intended for the delivery of fluids; including but not limited to; blood and blood products; from a container to a patient’s vascular system.                Several lots of the LifeShield Latex-Free HEMA Y-Type Blood Set IV Administration Set were assembled incorrectly.

Elekta; Inc.          Mar-06-2014      RT Desktop – RT DesktopThe EOS RT Desktop; as with the predicate SL/SLi Series user interface; is intended to be used as the user interface for the SL/SLi Series Linear Accelerators that are used for the radiation therapy treatments of malignant neoplastic diseases; as determined by a licensed medical practitioner.                During the treatment table; gantry; and collimator calibration procedures; it is possible to type incorrect values or invert a value.

Toshiba American Medical Systems Inc  Mar-06-2014      CT system – TSX-301C Aquilion One (Vision Edition) Computed Tomography X-Ray System.        Toshiba America Medical Systems; Inc. initiated this recall due to the failure of the parts used in the X-ray high-voltage generator. In some cases; X-ray exposure cannot be performed.

Mindray DS USA; Inc. dba Mindray North America            Mar-07-2014      Mindray DS USA; Inc. Panorama Patient Monitoring Network – Panaroma Central StationProduct Usage:  This device can view real time; store; print; graph; and trend patient clinical and demographic data. The device can also set independent alarm limits for data send by the bedside monitor.                Mindray has identified two issues with the Panorama Central Station. Full Disclosure data may lag behind the Panorama system time clock when the Panorama CentralStation is in use with Mindrays V-Series Monitor.  Additionally; event indicators lag behind the Panorama system time clock when the Panorama Central Station is in use with a Panorama Telepack.

Clarity Medical Systems Inc         Mar-07-2014      RetCam 3; RetCam Portable and RetCam Shuttle – RetCam 3; RetCam Portable and RetCam Shuttle; manufactured by Clarity Medical Systems; Inc.; Pleasanton; CA 94588.General ophthalmic imaging including retinal; corneal and external imaging. Software anomaly for RetCam 3; RetCam Shuttle and RetCam Portable with software versions 6.0.x; 6.1. x and 6.2x where the patients age is calculated incorrectly.

Shimadzu Medical Systems         Mar-07-2014      MUX-100; MUX-100H X-ray System – Mobile X-ray System; Model: MUX-100; MUX-100HProduct Usage:The device is a mobile X-ray system in order to take general radiography of patients in the hospital who cannnot move and/or of outpatients in emergency              Shimadzu Corporation is recalling the Shimadzu Mobile X-ray Sytems (MUX-100 and MUX-100H) because the connecting metal plate which connects the main chassis and the column of MUX-100 may crack.

Leica Biosystems Imaging; Inc.   Mar-07-2014      ScanScope System – HER2 Image AnalysisManual Read of HER2 Digital SlidesER/PR Image AnalysisIHC PR Breast Tissue Manual Read of Digital SlidesThe ScanScope System is an automated digital slide creation; management; viewing and analysis system. It is intended for in vitro diagnostic use as an aid to the pathologist in the display; detection; counting and classification of tissues and cells of clinical interest based on particular color; intensity; size; pattern and shape. The IHC HER2 Image Analysis application is intended for use as an aid to the pathologist in the detection and semi-quantitative measurement of HER2/neu (c-erbB-2) in formalin-fixed; paraffin-embedded normal and neoplastic tissue. The IHC HER2 Image Analysis application is intended for use as an accessory to the Dako HercepTest" to aid in the detection and semi-quantitative measurement of Her2/neu (c-erbB-2) in formalin-fixed; paraffin-embedded normal and neoplastic tissue. When used with the Dako HercepTest"; it is indicated for use as an aid in the assessment of breast cancer patients for whom HERCEPTIN(Trastuzumab) treatment is being considered. Note: The IHC HER2 Image Analysis application is an adjunctive computer-assisted methodology to assist the reproducibility of a qualified pathologist in the acquisition and measurement of images from microscope slides of breast cancer specimens stained for the presence of HER-2 receptor protein. The accuracy of the test result depends upon the quality of the immunohistochemical staining. It is the responsibility of a qualified pathologist to employ appropriate morphological studies and controls as specified in the instructions for the Dako HercepTest" to assure the validity of the IHC HER2 Image Analysis application assisted HER-2/neu score. The actual correlation of the Dako HercepTest" to Herceptin clinical outcome has not been established. Manual Read of HER2 Digital Slides: The ScanScope System is an automated digital slide creation; management; viewing and analysis system. It is intended for in vitro diagnostic use as an aid to the pathologist in the display; detection; counting and classification of tissues and cells of clinical interest based on particular color; intensity; size; pattern and shape. The IHC HER2 Manual Read of Digital Slides application is intended for use as an aid to the pathologist in the detection and semi-quantitative measurement of HER-2/neu (c-erbB-2) by manual examination of the digital slide of formalin-fixed; paraffin-embedded normal and neoplastic tissue immunohistochemically stained for HER-2 receptors on a computer monitor. HER-2 results are indicated for use as an aid in the management; prognosis and prediction of therapy outcomes of breast cancer. The IHC HER2 Manual Read of Digital Slides application is intended for use as an accessory to the Dako HercepTestT to aid the pathologist in the detection and semi-quantitative measurement of HER-2/neu (c-erbB-2) by manual examination of the digital slide of formalin-fixed; paraffin-embedded normal and neoplastic tissue immunohistochemically stained for HER-2 receptors on a computer monitor. When used with the Dako HercepTestT; it is indicated for use as an aid in the assessment of breast cancer patients for whom HERCEPTIN (Trastuzumab) treatment is being considered. Note: The actual correlation of the Dako HercepTestT to Herceptin clinical outcome has not been established. ER/PR Image Analysis: The ScanScope XT System is an automated digital slide creation; management; viewing and analysis system. It is intended for in vitro diagnostic use as an aid to the pathologist in the display; detection; counting and classification of tissues and cells of clinical interest based on particular color; intensity; size; pattern and shape. The IHC ER Image Analysis application is intended for use as an aid to the pathologist in the detection and quantitative measurement of ER (Estrogen Receptor) in formalin-fixed paraffin-embedded normal and neo In an abundance of caution; Aperio (now known as Lecia Biosystems) is providing additional information to clarify that the use of Digital IHC Breast/ER/Dako Image Analysis; Digital IHC Breast/HER2 Digital Read; Digital IHC Breast/HER2/Dako Image Analysis; Digital IHC Breast/PR Digital Read and Digital IHC Breast/PR/Dako Image Analysis with the RUO products identified in that earlier notification i

Philips Medical Systems; Inc.      Mar-07-2014      Philips Healthcare MRx – Philips HeartStart MRx  Monitor/DefibrillatorModel numbers: M3535A; M3536A; M3536M;M3536M4;M3536M6;861288;861289;861464;861483;and 861491   MRx may display a Red X in the Ready For Use (RFU) indicator during automated tests informing the user that a failure has been detected that may prevent the delivery of a shock and pacing

Elekta; Inc.          Mar-07-2014      Medical Linear Accelerator – All Elekta digital accelerators with electrons and beam modulator; MLCi/MLCi2; Agility or Asymmetric HeadsProduct Usage: Deliver of radiation to defined target volumes                Customers are resetting the default values outside recommended factory settings.

Carl Zeiss Meditec AG    Mar-07-2014      VisuMax Laser Keratome – Treatment packs used on the VisuMax Laser Keratome.Size MManufactured by Carl Zeiss Meditec AG;Jena; Germany.The VisuMax Laser Keratome is indicated for the following: In the creation of a corneal flap in patients undergoing LASIK surgery or other treatment requiring lamellar resection of the cornea. Patients undergoing surgery or other treatment requiring initial lamellar resection of the cornea. In the creation of a lamellar cut/resection of the cornea for lamellar keratoplasty. In the creation of a cut/incision for penetrating keratoplasty and corneal harvesting.             Carl Zeiss Treatment pack; lot number M 130010; size M; may actually contain size S.

Megadyne Medical Products; Inc.            Mar-07-2014      MEGADYNE MEDICAL PRODUCTS "12FR" SUCTION COAGULATOR – Hand Control 12FR Suction Coagulator with 10 ft cord and holster; Sterile; Disposable; Model Number 0043-25; packaged Tyvek polyester peel pouch; 25 pouches per box.This device is intended to conduct monopolar electrosurgical energy from an electrosurgical generator (ESU) to target tissue during ENT and general surgical procedures. It is also a suction apparatus used to remove surgical smoke and fluids from the site. The device is intended for single use; it is not intended to be cleaned or reused.          Megadyne Medical Products; Inc. is voluntarily recalling Hand Control 12Fr Suction Coagulator with 10ft cord and 132405 Holster; Sterile; Disposable; Lot 132405 due to the potential for a small number of these suction coagulators to self-activate immediately on connection to the electrosurgical generatorand to remain activated until it is disconnected.

Maquet Cardiovascular Us Sales; Llc        Mar-10-2014      MAQUET – MAQUET PLEGIOX Cardioplegia Heat ExchangerThe PLEGIOX Cardioplegia Heat Exchanger is used as part of a cardioplegia system to set and maintain temperature for given flow rates and within the given temperature range of blood cardioplegic and crystalloid cardioplegic solutions during extracorporeal circulation. The product is designed for single use only; for an application period of no longer than 6 hours.                The MAQUET post-marketing vigilance program has identified a discrepancy that thedesired cardioplegia temperature may not be obtained when the PLEGIOX CardioplegiaHeat Exchanger (PLEGIOX) is used in conjunction with a heater/cooler unit.

Smith & Nephew Inc.     Mar-10-2014      RENASYS-AB Abdominal Dressing Kit with Soft Port – Smith & Nephew  RENASYS-AB Abdominal Dressing Kit with Soft Port REF #’s: 66800980  (The RENASYS Soft Port Dressing Kits are used in conjunction with negative pressure wound therapy pumps)          Reports of wound fluid and /or blood that were not evacuated from beneath the wound dressing and the pump blockage alarm did not activate has been associated with inadequate Soft Port sealing at the wound site or improper positioning of the Soft Port orifice over the wound contact dressing drape.  Inadequate sealing can result in air leaks and contribute to inefficient fluid evacuation from the wo

Smith & Nephew Inc.     Mar-10-2014      RENASYS Soft Port Dressing Kits – Smith & Nephew  RENASYS Soft Port  REF: 66800799 (The RENASYS Soft Port Dressing Kits are used in conjunction with negative pressure wound therapy pumps)                Reports of wound fluid and /or blood that were not evacuated from beneath the wound dressing and the pump blockage alarm did not activate has been associated with inadequate Soft Port sealing at the wound site or improper positioning of the Soft Port orifice over the wound contact dressing drape.  Inadequate sealing can result in air leaks and contribute to inefficient fluid evacuation from the wo

Smith & Nephew Inc.     Mar-10-2014      RENASYS-F Foam Dressing Kit with Soft Port – Smith & Nephew  RENASYS-F Foam Dressing Kit with Soft Port  REF #’s: 66800794; 66800795; and 66800796 (The RENASYS Soft Port Dressing Kits are used in conjunction with negative pressure wound therapy pumps)       Reports of wound fluid and /or blood that were not evacuated from beneath the wound dressing and the pump blockage alarm did not activate has been associated with inadequate Soft Port sealing at the wound site or improper positioning of the Soft Port orifice over the wound contact dressing drape.  Inadequate sealing can result in air leaks and contribute to inefficient fluid evacuation from the wo

Smith & Nephew Inc.     Mar-10-2014      RENASYS-F XL with Soft Port – Smith & Nephew  RENASYS-F XL with Soft Port  REF #: 66800797  (The RENASYS Soft Port Dressing Kits are used in conjunction with negative pressure wound therapy pumps)                Reports of wound fluid and /or blood that were not evacuated from beneath the wound dressing and the pump blockage alarm did not activate has been associated with inadequate Soft Port sealing at the wound site or improper positioning of the Soft Port orifice over the wound contact dressing drape.  Inadequate sealing can result in air leaks and contribute to inefficient fluid evacuation from the wo

Smith & Nephew Inc.     Mar-10-2014      RENASYS-Gauze with Soft Port Kit – Smith & Nephew  RENASYS-Gauze with Soft Port Kit  REF #’s: 66800933; 66800934; 66800935; and 66800936  (The RENASYS Soft Port Dressing Kits are used in conjunction with negative pressure wound therapy pumps)                Reports of wound fluid and /or blood that were not evacuated from beneath the wound dressing and the pump blockage alarm did not activate has been associated with inadequate Soft Port sealing at the wound site or improper positioning of the Soft Port orifice over the wound contact dressing drape.  Inadequate sealing can result in air leaks and contribute to inefficient fluid evacuation from the wo

Smith & Nephew Inc.     Mar-10-2014      RENASYS-G Sterile; Gauze Dressing Kit with Soft Port – Smith & Nephew  RENASYS-G Sterile; Gauze Dressing Kit with Soft Port REF #’s: 66800961  (The RENASYS Soft Port Dressing Kits are used in conjunction with negative pressure wound therapy pumps)                Reports of wound fluid and /or blood that were not evacuated from beneath the wound dressing and the pump blockage alarm did not activate has been associated with inadequate Soft Port sealing at the wound site or improper positioning of the Soft Port orifice over the wound contact dressing drape.  Inadequate sealing can result in air leaks and contribute to inefficient fluid evacuation from the wo

Boston Scientific Corporation     Mar-10-2014      Boston Scientific RunWay" Guide Catheter – Boston Scientific; RunWay" Guide Catheter; UPN H749389696640; Catalog Number 38969-664.           Boston Scientific is initiating this Recall Removal of one lot (2013040058) of the RunWay" Guide Catheter. Boston Scientific has become aware that the sterile pouch of the devices from this lot may not be completely sealed and sterility may be compromised. To date; Boston Scientific has received one complaint for thisissue. The most common adverse health consequence expected from an unsealed pou

GE Healthcare; LLC          Mar-10-2014      X-ray System – GE Healthcare; Innova 2100IQ; Innova 3100; Innova 3100IQ; Innova 4100; Innova 4100IQ Innova 2121IQ; Innova 3131IQ; Cardiovascular X-ray imaging systems (X-ray generator installed with Rotor V3 version and Heater V4 version boards).The Digital Fluoroscopic Imaging System is indicated for use in generating fluoroscopic images of human anatomy for diagnostic and intervention angiography procedures. It is intended to replace fluoroscopic images obtained through the image intensifier technology. This device is not intended for mammography applications. The Innova 3100 system is indicated for use in generating fluoroscopic images of human anatomy for vascular angiography; and optionally; rotational and angiography procedures. It is intended to replace fluoroscopic images obtained through image intensifier technology. The Digital Fluoroscopic Imaging System is indicated for use in diagnostic and interventional angiographic procedures of human anatomy. It is intended to replace image intensifier fluoroscopic systems in all diagnostic or interventional procedures. This device is not intended for mammography applications. A new tilt table will support performing procedures like CO2 studies; Venography.  The Digital Fluoroscopic Imaging System with Bolus Chasing option is indicated for use in generating fluoroscopic images of human anatomy for diagnostic and intervention; the option Bolus enables to perform subtraction angiography of lower limbs. This device is not intended for mammography applications. The Innova 2100-IQ system is indicated for use in generating fluoroscopic images of human anatomy for vascular angiography diagnostic and interventional procedures; and optionally; rotational angiography procedures. It is also indicated for generating fluoroscopic images of human anatomy for cardiology diagnostic and interventional procedures. It is intended to replace fluoroscopic images obtained through image intensifier technology. This device is not intended for mammography applications.  For Innova 4100; Innova 4100IQ; Innova 3100; Innova 3100 IQ; Innova 2100IQ with Innova 3T Option: The Innova systems are indicated for use in generating fluoroscopic images of human anatomy for vascular angiography; diagnostic and interventional procedures; and optionally; rotational imaging procedures. They are also indicated for generating fluoroscopic images of human anatomy for cardiology; diagnostic; and interventional procedures. They are intended to replace fluoroscopic images obtained through image intensifier technology. Those devices are not intended for mammography applications. Innova CT is a software option; which reconstructs 3D volumes from Rotational Fluoroscopy acquisition to provide images that assist the physician in diagnosis; surgical planning; interventional procedures and treatment follow-up. Innova CT is intended for imaging bone and soft tissues as well as other internal body structures. Innova CT is not intended for mammography applications. For Innova 4100; Innova 4100IQ; Innova 3100; Innova 3100 IQ; Innova 2100IQ with Innova 3D or InnovaSpin option: The Innova systems are indicated for use in generating fluoroscopic images of human anatomy for vascular angiography; diagnostic and interventional procedures; and optionally; rotational imaging procedures. They are also indicated for generating fluoroscopic images of human anatomy for cardiology; diagnostic; and interventional procedures. They are intended to replace fluoroscopic images obtained through image intensifier technology. Those devices are not intended for mammography applications. Innova 3D is a software option which reconstructs 3D volumes from Rotational Fluoroscopy acquisition to assist the physician in diagnosis; surgical planning; interventional procedures and treatment follow-up. It is not intended for mammography applications. InnovaSpin is a software option that permits fast spin rotational angiography. It is not intended for mammography applications. :    GE Healthcare has become aware of a potential safety issue involving the innova systems. The Innova system can unexpectedly stop delivering X-rays after a power-on or a reset cycle which may result in the loss of real-time interventional imaging. No injuries have been reported due to this issue.

Steris Corporation           Mar-10-2014      VERIFY SixCess 270FP Challenge Pack – VERIFY SixCess 270FP Challenge Pack; STERIS Corporation; 5960 Heisley Road; Mentor; OH 44060; 440-354-2600.The VERIFY SixCess 270FP Challenge Pack is used to monitor steam sterilization loads processed at 270F using typical healthcare dynamic air removal steam sterilization cycles.                STERIS has identified that the outer shipping package for one lot (Lot #024552A) of VERIFY SixCess Challenge Packs incorrectly identifies the lot as Lot #024522A.

Synthes; Inc.      Mar-11-2014      Synthes Small Notch Titanium Reconstrcutive Plate – Synthes Small Notch Titanium Reconstructive PlateProduct Usage:The Synthes Small Notch Titanium Reconstructive Plate set offers fixation for immediate stabilization to allow bone fusion. Commercially pure titanium implants are biocompatible. The wide selection of implants accommodates variable anatomy; precisely crafted instruments facilitate implant placement. Implant plate lateral slant of holes allows for angulation of screws. Elongated central holes provide flexibility in screw placement. Wide selection of length’s accommodates individual case requirements.              Certain modules containing the Synthes Small Notch Titanium Reconstructive Plate set was distributed by Spine sales consultants although it was contraindicated for certain spine applications.

Biosense Webster; Inc. Mar-11-2014      PENTARAY NAV Catheter – PENTARAY NAV High-Density Mapping Catheter; Catalog No. D128201; D128202; D128204; D128205.The Biosense Webster PENTARAY NAV High-Density Mapping Catheter is indicated for multiple electrode electrophysiological mapping of cardiac structures in the heart; i.e.; recording or stimulation only. This catheter is intended to obtain electrograms in the atrial and ventricular regions of the heart.                Biosense Webster is recalling the PentaRay Nav Catheter because it has the potential to have partial tip separation from the catheter shaft.

GE Healthcare; LLC          Mar-11-2014      GE Healthcare CARESCAPE Monitor B650 and CARESCAPE Monitor B850. – GE Healthcare CARESCAPE Monitor B650 and CARESCAPE Monitor B850.K102239 CARESCAPE Monitor B650 The CARESCAPE Monitor B650 is a multi-parameter patient monitor intended for use in multiple areas and intra-hospital transport within a professional healthcare facility. The CARESCAPE Monitor B650 is intended for use on adult; pediatric; and neonatal patients and on one patient at a time. The CARESCAPE Monitor B650 is indicated for monitoring and recording of; and to generate alarms for; hemodynamic (including ECG; ST segment; arrhythmia detection; ECG diagnostic analysis and measurement; invasive pressure; non-invasive blood pressure; pulse oximetry; cardiac output; temperature and mixed venous oxygen saturation); impedance respiration; airway gases (CO2; O2; N2O and anesthetic agents); spirometry; gas exchange; and neurophysiological (including electroencephalography; Entropy; Bispectral Index (BIS) and neuromuscular transmission(NMT) status. The CARESCAPE Monitor B650 can be a stand-alone monitor or interfaced to other devices. It can also be connected to other monitors for remote viewing and to data management software devices via a network. The CARESCAPE Monitor B650 is intended for use under the direct supervision of a licensed healthcare practitioner; or by personnel trained in proper use of the equipment in a professional healthcare facility. The CARESCAPE Monitor B650 is not intended for use during MRI. K092027 CARESCAPE Monitor B850 The CARESCAPE Monitor B850 is a multi-parameter high acuity patient monitor intended for use in multiple areas within a professional healthcare facility. The CARESCAPE Monitor B850 is intended for use on adult; pediatric; and neonatal patients and on one patient at a time. The CARESCAPE Monitor B850 system is indicated for monitoring of Hemodynamic (including ECG; ST Segment; Arrhythmia Detection; ECG Diagnostic Analysis and Measurement; Invasive Pressure; Noninvasive Blood Pressure; Pulse Oximetry; Cardiac Output; Temperature; Impedance Respiration and SvO2 (Mixed Venous Oxygen Saturation); Airway Gases (Fi/Et C02; 02; N20 and Anesthetic Agent); Spirometry; Gas Exchange (02 Consumption (VO2); C02 production (VCO2); energy expenditure (BE); and respiratory quotient (RQ)) and neurophysiological (including electroencephalography (EEG); Entropy; Bispectral Index (BIS) and Neuromuscular Transmission (NMT) Monitoring) status. The CARESCAPE Monitor B850 provides alarms; trends; snapshots and events; and calculations and can be connected to displays; printers and recording devices. The CARESCAPE Monitor B850 can be a stand-alone monitor or interfaced to other devices. It can also be connected to other monitors for bed to bed viewing and to data management software devices via a network. The CARESCAPE Monitor B850 is intended for use under the direct supervision of a licensed healthcare practitioner; or by personnel trained in proper use of the equipment in a professional healthcare facility. In addition to the healthcare practitioner; the CARESCAPE Monitor B850 is designed to provide configuration and troubleshooting capabilities to qualified service personnel. The CARESCAPE Monitor B850 is not intended for use during MRI. K131414 CARESCAPE MONITOR B850 The CARESCAPE Monitor B850 is a multi-parameter high acuity patient monitor intended for use in multiple areas within a professional healthcare facility. The CARESCAPE Monitor B850 is intended for use on adult; pediatric; and neonatal patients and on one patient at a time. The CARESCAPE Monitor B850 system is indicated for monitoring of Hemodynamic (including ECG; ST Segment; Arrhythmia Detection; ECG Diagnostic Analysis and Measurement; Invasive Pressure; Noninvasive Blood Pressure; Pulse Oximetry; Cardiac Output; Thermodilution and pulse contour); Temperature; Mixed Venous Oxygen Saturation; and Central Venous Oxygen Saturation). Respiratory [Impedance Respiration; Airway Gases (C02; 02; N20 and Anesthetic Agents); Spirometry; Gas Exchange] and N     GE Healthcare has recently become aware of potential safety issues associated with the CARESCAPE Monitor B850 and CARESCAPE Monitor B650.  These issues include both NIBP (Non-Invasive Blood Pressure)  and Bed to Bed Issues.

Horiba Instruments; Inc dba Horiba Medical        Mar-11-2014      ABX PENTRA ML – Device Name: ABX PENTRA MLModel/Part #(s): A11A01652Lot/Serial #(s): N/ASoftware Version(s): All versions are subject to this correction.Product Usage:The ABX PENTRA ML is a software data management system intended for use on ABX Hematology Analyzers.                HORIBA Medical initiated this recall of all software versions of ABX PENTRA ML (Model A11A06152) due to a software bug with the potential of transmitting incorrect results to the Laboratory Information System.

Accumetrics Inc                Mar-11-2014      VerifyNow IIb/IIIa Test – VerifyNow IIb/IIIa Test; Catalog No. 85310; 10-Test Kit and Catalog No. 85011; 25-Test kit.Product  Usage:The VerifyNow System is a turbidimetric based optical detection system which measures platelet-induced aggregation. The system consists of an instrument; a disposable test device and quality control materials. The VerifyNow IIb/IIIa Test is a semi-quantitative; whole blood platelet function test used to measure glycoprotein (GP) IIb/IIIa receptor blockade in patients treated with abciximab or eptifibatide. VerifyNow Ilb/Illa Test results should be interpreted in conjunction with other clinical and laboratory data available to the clinician.        Accumetrics is recalling the VerifyNow IIb/IIIa test because it may result in the reporting of an erroneous low platelet aggregation unit (PAU) result.   An erroneous low PAU result may cause a low percent inhibition calculation or low baseline PAU.

Smiths Medical ASD; Inc.              Mar-12-2014      Portex Arterial Blood Sampling Line Draw Syringes – G2001: 3 mL Line Draw; Luer slip syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro device; Needle-Pro Device and 23G x 1 needleArterial Blood Sampling Line Draw Syringes are sterile; single-use devices; in-vitro diagnostic devices used for the drawing of arterial blood via an arterial line. The product is not for injection.        issue with the plunger tip of the Portex Arterial Blood Sampling Line Draw Syringes

Smiths Medical ASD; Inc.              Mar-12-2014      Portex Arterial Blood Sampling Line Draw Syringes – 4043W-2: 3 mL Line Draw; Luer slip syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro device; syringe tip cap and 6 mL Luer slip syringe Arterial Blood Sampling Line Draw Syringes are sterile; single-use devices; in-vitro diagnostic devices used for the drawing of arterial blood via an arterial line. The product is not for injection.        issue with the plunger tip of the Portex Arterial Blood Sampling Line Draw Syringes

Smiths Medical ASD; Inc.              Mar-12-2014      Portex Arterial Blood Sampling Line Draw Syringes – G1762: 3 mL Line Draw; Luer lock syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro device; syringe tip cap; and 5 mL Luer lock syringeArterial Blood Sampling Line Draw Syringes are sterile; single-use devices; in-vitro diagnostic devices used for the drawing of arterial blood via an arterial line. The product is not for injection.        issue with the plunger tip of the Portex Arterial Blood Sampling Line Draw Syringes

Smiths Medical ASD; Inc.              Mar-12-2014      Portex Arterial Blood Sampling Line Draw Syringes – G1725: 3 mL Line Draw; Luer slip syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro device and 1 mL Line Draw Luer slip syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro device Arterial Blood Sampling Line Draw Syringes are sterile; single-use devices; in-vitro diagnostic devices used for the drawing of arterial blood via an arterial line. The product is not for injection.      issue with the plunger tip of the Portex Arterial Blood Sampling Line Draw Syringes

Smiths Medical ASD; Inc.              Mar-12-2014      Portex Arterial Blood Sampling Line Draw Syringes – 4040-2: Umbilical 3 mL Line Draw; Luer lock syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro device; 22g x 1 needle; and Point-Lok needle safety deviceArterial Blood Sampling Line Draw Syringes are sterile; single-use devices; in-vitro diagnostic devices used for the drawing of arterial blood via an arterial line. The product is not for injection.              issue with the plunger tip of the Portex Arterial Blood Sampling Line Draw Syringes

Smiths Medical ASD; Inc.              Mar-12-2014      Portex Arterial Blood Sampling Line Draw Syringes – G1777:  Umbilical (2) 3 mL Line Draw; Luer lock syringes (heparin concentration: 23.5 I.U. per mL) with Filter-Pro devices and (2) Needle-Pro Devices with 22G x 1needlesArterial Blood Sampling Line Draw Syringes are sterile; single-use devices; in-vitro diagnostic devices used for the drawing of arterial blood via an arterial line. The product is not for injection.              issue with the plunger tip of the Portex Arterial Blood Sampling Line Draw Syringes

Smiths Medical ASD; Inc.              Mar-12-2014      Portex Arterial Blood Sampling Line Draw Syringes – 4043G-2: 3 mL Line Draw; Luer slip syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro device and ice bag Arterial Blood Sampling Line Draw Syringes are sterile; single-use devices; in-vitro diagnostic devices used for the drawing of arterial blood via an arterial line. The product is not for injection.       issue with the plunger tip of the Portex Arterial Blood Sampling Line Draw Syringes

Smiths Medical ASD; Inc.              Mar-12-2014      Portex Arterial Blood Sampling Line Draw Syringes – 4042LH:  3 mL Line Draw; Luer lock syringe (heparin concentration: 7 I.U. per mL)with Filter-Pro device  Arterial Blood Sampling Line Draw Syringes are sterile; single-use devices; in-vitro diagnostic devices used for the drawing of arterial blood via an arterial line. The product is not for injection.                issue with the plunger tip of the Portex Arterial Blood Sampling Line Draw Syringes

Smiths Medical ASD; Inc.              Mar-12-2014      Portex Arterial Blood Sampling Line Draw Syringes – 4043E: 3 mL Line Draw; Luer slip syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro device (for sale in Europe only)Arterial Blood Sampling Line Draw Syringes are sterile; single-use devices; in-vitro diagnostic devices used for the drawing of arterial blood via an arterial line. The product is not for injection.           issue with the plunger tip of the Portex Arterial Blood Sampling Line Draw Syringes

Smiths Medical ASD; Inc.              Mar-12-2014      Portex Arterial Blood Sampling Line Draw Syringes – 4042-2: 3 mL Line Draw; Luer lock syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro device Arterial Blood Sampling Line Draw Syringes are sterile; single-use devices; in-vitro diagnostic devices used for the drawing of arterial blood via an arterial line. The product is not for injection.         issue with the plunger tip of the Portex Arterial Blood Sampling Line Draw Syringes

Smiths Medical ASD; Inc.              Mar-12-2014      Portex Arterial Blood Sampling Line Draw Syringes – 4042E:  3 mL Line Draw; Luer lock syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro device (for sale in Europe only)Arterial Blood Sampling Line Draw Syringes are sterile; single-use devices; in-vitro diagnostic devices used for the drawing of arterial blood via an arterial line. The product is not for injection.           issue with the plunger tip of the Portex Arterial Blood Sampling Line Draw Syringes

Smiths Medical ASD; Inc.              Mar-12-2014      Portex Arterial Blood Sampling Line Draw Syringes – G1469J: 3 mL Line Draw; Luer slip syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro device (for sale in Japan only) Arterial Blood Sampling Line Draw Syringes are sterile; single-use devices; in-vitro diagnostic devices used for the drawing of arterial blood via an arterial line. The product is not for injection.           issue with the plunger tip of the Portex Arterial Blood Sampling Line Draw Syringes

Smiths Medical ASD; Inc.              Mar-12-2014      Portex Arterial Blood Sampling Line Draw Syringes – 4043-2: 3 mL Line Draw; Luer slip syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro device Arterial Blood Sampling Line Draw Syringes are sterile; single-use devices; in-vitro diagnostic devices used for the drawing of arterial blood via an arterial line. The product is not for injection.         issue with the plunger tip of the Portex Arterial Blood Sampling Line Draw Syringes

Lin-Zhi International Inc                Mar-12-2014      Drugs of abuse urinalysis (DAU) cTHC (Cannabinoid) Control Level 2 (62.5 ng/ml) – Cannabinoids DAU Calibrator Control Level 1 (62.5 ng/mL)This solution is prepared from non-sterile urine and should be handled as potentially infectious.IVD;The Cannabinoids (cTHC also known as THC version c) DAU negative and positive controls are human urine-based liquids and ready to use. The constituent is a processed drug-free human urine matrix; containing buffers; stabilizers; and less than 0.09 % of sodium azide. The controls are prepared by spiking known concentrations of 11-nor-9-THC-9-COOH into the drug-freematrix. cTHC is referenced as an abbreviation for 11-nor-9-THC-9-COOH and it may be referred to simply as THC in the text of this report. The controls contain 37.5 ng/mL and 62.5 ng/mL of cTHC; 10% by GC/MS or LC/MS analysis.Lin Zhi International inc.Sunnyvale; CA 94085The Cannabinoid Drug of Abuse (DAU) negative and positive controls are used as assay quality control material to monitor the precision of the Lin-Zhi International; Inc. (LZI) Cannabinoid Enzyme Immunoassay (Ref # 0070c) on a number of automated clinical chemistry analyzers.            Product catalog #s 0007c Cannabinoid 37.5 ng/mL Control Level 1 and 0008c Cannabinoid62.5 Control Level 2 of the lots mentioned may give decreased concentration readings towardsthe end of their shelf life due to use of dated but unexpired secondary stock used to create theproducts.

Lin-Zhi International Inc                Mar-12-2014      Drugs of abuse urinalysis (DAU) cTHC (Cannabinoid) Control Level 1 (37.5ng/ml) – Cannabinoids DAU Calibrator Control Level 1 (37.5 ng/mL)This solution is prepared from non-sterile urine and should be handled as potentially infectious.IVD;The Cannabinoids (cTHC also known as THC version c) DAU negative and positive controls are human urine-based liquids and ready to use. The constituent is a processed drug-free human urine matrix; containing buffers; stabilizers; and less than 0.09 % of sodium azide. The controls are prepared by spiking known concentrations of 11-nor-9-THC-9-COOH into the drug-freematrix. cTHC is referenced as an abbreviation for 11-nor-9-THC-9-COOH and it may be referred to simply as THC in the text of this report. The controls contain 37.5 ng/mL and 62.5 ng/mL of cTHC; 10% by GC/MS or LC/MS analysis.Lin Zhi International inc.Sunnyvale; CA 94085The Cannabinoid Drug of Abuse (DAU) negative and positive controls are used as assay quality control material to monitor the precision of the Lin-Zhi International; Inc. (LZI) Cannabinoid Enzyme Immunoassay (Ref # 0070c) on a number of automated clinical chemistry analyzers.            Product catalog #s 0007c Cannabinoid 37.5 ng/mL Control Level 1 and 0008c Cannabinoid62.5 Control Level 2 of the lots mentioned may give decreased concentration readings towardsthe end of their shelf life due to use of dated but unexpired secondary stock used to create theproducts.

Biomerieux Inc  Mar-12-2014      bioMerieux PREVI Isola System – bioMerieux PREVI Isola System (General purpose;microbiology; diagnostic Medical Device); (REF 29500/29500R); bioMerieux; Hazelwood; MO.   The firm has determined the product may fail to dispense the sample to the agar plate resulting in a "failure to dispense" in conjunction with urine specimens. This could lead to a "false" negative growth result.

Philips Medical Systems; Inc.      Mar-12-2014      Phillips HeartStart MRx Monitor/Defribillator – Philips HeartStart MRx Monitor/DefibrillatorModels: M3535A and M3536A with Q-CPR Meter Option B08The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained in the operation of the device and qualified by training in basic life support; advanced cardiac support; or defibrillation. It must be used by or on the order of a physician  When the HeartStart MRx.is used with the Q-CPR Meter in defibrillation mode; the Q-CPR Meter may incorrectly display the Do Not Touch the Patient icon.

Biomet 3i; LLC    Mar-12-2014      Contra-Angle Torque Driver Kit – Contra-Angle Torque Driver KitProduct Usage:  Molded plastic tray used in holding various dental instruments for autoclave processing.                During recent revised sterilization validation testing; the included surgical trays did not meet the Sterility Assurance Level required.

Biomet 3i; LLC    Mar-12-2014      Navigator Surgical Kit – Navigator Surgical KitProduct Usage:  Molded plastic tray used in holding various dental instruments for autoclave processing.      During recent revised sterilization validation testing; the included surgical trays did not meet the Sterility Assurance Level required.

Biomet 3i; LLC    Mar-12-2014      Contra-Angle Torque Driver Kit – Contra-Angle Torque Driver Kit For Certain and External ConnectionProduct Usage:  Molded plastic tray used in holding various dental instruments for autoclave processing.                During recent revised sterilization validation testing; the included surgical trays did not meet the Sterility Assurance Level required.

Biomet 3i; LLC    Mar-12-2014      Contra-Angle Torque Driver Kit – Contra-Angle Torque Driver Kit For Certain Internal ConnectionProduct Usage:  Molded plastic tray used in holding various dental instruments for autoclave processing.                During recent revised sterilization validation testing; the included surgical trays did not meet the Sterility Assurance Level required.

Biomet 3i; LLC    Mar-12-2014      Tapered Navigator Certain Surgical Kit – Tapered Navigator Certain Surgical KitProduct Usage:  Molded plastic tray used in holding various dental instruments for autoclave processing.               During recent revised sterilization validation testing; the included surgical trays did not meet the Sterility Assurance Level required.

DePuy Orthopaedics; Inc.             Mar-13-2014      S-ROM Noiles Rotating Hinge Femur with Pin – REF 623411 R S-ROM Noiles Rotating Hinge; Femoral Rotating Hinge Cemented (with Pin); Right; Small;  Sterile RQty 1The S-ROM Hinged knee femoral component is used in revision surgeries when there is significant bone loss or ligament instability and additional support is needed. S-Rom femorals and inserts are brought into nearly every revision case as backup should the MCL become compromised during the procedure. If additional constraint is required the surgeon can use the S-ROM femoral and insert. S-ROM femorals are used in less than 10% of knee revision procedures; but are present almost all the time.       DePuy Orthopaedics has identified the potential for holes to develop in the inner and outer flexible pouches that form the sterile barrier for S-ROM Noiles Rotating Hinge Femur with Pin devices. The outer carton and shrink wrap are intact. A package redesign is underway to resolve this issue. S-ROM Noiles Rotating Hinge Femur with Pin devices will remain in US Distributors inventory during the pa

DePuy Orthopaedics; Inc.             Mar-13-2014      S-ROM Noiles Rotating Hinge Femur with Pin – REF 623421 L S-ROM Noiles Rotating Hinge; Femoral Rotating Hinge Cemented (with Pin); Left ; X-Small;  Sterile RQty 1The S-ROM Hinged knee femoral component is used in revision surgeries when there is significant bone loss or ligament instability and additional support is needed. S-Rom femorals and inserts are brought into nearly every revision case as backup should the MCL become compromised during the procedure. If additional constraint is required the surgeon can use the S-ROM femoral and insert. S-ROM femorals are used in less than 10% of knee revision procedures; but are present almost all the time.       DePuy Orthopaedics has identified the potential for holes to develop in the inner and outer flexible pouches that form the sterile barrier for S-ROM Noiles Rotating Hinge Femur with Pin devices. The outer carton and shrink wrap are intact. A package redesign is underway to resolve this issue. S-ROM Noiles Rotating Hinge Femur with Pin devices will remain in US Distributors inventory during the pa

DePuy Orthopaedics; Inc.             Mar-13-2014      S-ROM Noiles Rotating Hinge Femur with Pin – REF 623421 RS-ROM Noiles Rotating Hinge; Femoral Rotating Hinge Cemented (with Pin); Right ; X-Small;  Sterile RQty 1The S-ROM Hinged knee femoral component is used in revision surgeries when there is significant bone loss or ligament instability and additional support is needed. S-Rom femorals and inserts are brought into nearly every revision case as backup should the MCL become compromised during the procedure. If additional constraint is required the surgeon can use the S-ROM femoral and insert. S-ROM femorals are used in less than 10% of knee revision procedures; but are present almost all the time.                DePuy Orthopaedics has identified the potential for holes to develop in the inner and outer flexible pouches that form the sterile barrier for S-ROM Noiles Rotating Hinge Femur with Pin devices. The outer carton and shrink wrap are intact. A package redesign is underway to resolve this issue. S-ROM Noiles Rotating Hinge Femur with Pin devices will remain in US Distributors inventory during the pa

Gyrus Medical; Inc           Mar-13-2014      Gyrus ACMI Disposable Falope-Ring Band Applicator Kits – Gyrus ACMI Disposable Falope-Ring Band Applicator Kits.  REF 006889-901 and REF 005280-901 (with 8 mm Disposable Trocan).  Sterile EO.  Single Use Only.The disposable Falope-Ring Band Applicator is a sterile; two-band; dual-incision instrument.  The two-band applicator enables the physician to occlude both Fallopian tubes without removing the applicator from the abdominal cavity.  The Falope-Ring Band and Applicator Kits are indicated for use for female sterilization (permanent contraception).                Due to an anomaly in the packaging process for specific lots of Disposable Falope-Ring Band Kit; it is possible that a defective seal could be present that may allow a breach of the package’s sterile barrier and may compromise the sterility of the product.  The breach may or may not be easily seen.

DePuy Orthopaedics; Inc.             Mar-13-2014      S-ROM Noiles Rotating Hinge Femur with Pin – REF 623401 LS-ROM Noiles Rotating Hinge; Femoral Rotating Hinge Cemented (with Pin); Left; medium;  Sterile RQty 1The S-ROM Hinged knee femoral component is used in revision surgeries when there is significant bone loss or ligament instability and additional support is needed. S-Rom femorals and inserts are brought into nearly every revision case as backup should the MCL become compromised during the procedure. If additional constraint is required the surgeon can use the S-ROM femoral and insert. S-ROM femorals are used in less than 10% of knee revision procedures; but are present almost all the time.                DePuy Orthopaedics has identified the potential for holes to develop in the inner and outer flexible pouches that form the sterile barrier for S-ROM Noiles Rotating Hinge Femur with Pin devices. The outer carton and shrink wrap are intact. A package redesign is underway to resolve this issue. S-ROM Noiles Rotating Hinge Femur with Pin devices will remain in US Distributors inventory during the

DePuy Orthopaedics; Inc.             Mar-13-2014      S-ROM Noiles Rotating Hinge Femur with Pin – REF 623411 L; S-ROM Noiles Rotating Hinge; Femoral Rotating Hinge Cemented (with Pin); Left; Small;  Sterile RQty 1The S-ROM Hinged knee femoral component is used in revision surgeries when there is significant bone loss or ligament instability and additional support is needed. S-Rom femorals and inserts are brought into nearly every revision case as backup should the MCL become compromised during the procedure. If additional constraint is required the surgeon can use the S-ROM femoral and insert. S-ROM femorals are used in less than 10% of knee revision procedures; but are present almost all the time.       DePuy Orthopaedics has identified the potential for holes to develop in the inner and outer flexible pouches that form the sterile barrier for S-ROM Noiles Rotating Hinge Femur with Pin devices. The outer carton and shrink wrap are intact. A package redesign is underway to resolve this issue. S-ROM Noiles Rotating Hinge Femur with Pin devices will remain in US Distributors inventory during the p

DePuy Orthopaedics; Inc.             Mar-13-2014      S-ROM Noiles Rotating Hinge Femur with Pin – REF 623401 R; S-ROM Noiles Rotating Hinge; Femoral Rotating Hinge Cemented (with Pin); Right; Medium;  Sterile RQty 1The S-ROM Hinged knee femoral component is used in revision surgeries when there is significant bone loss or ligament instability and additional support is needed. S-Rom femorals and inserts are brought into nearly every revision case as backup should the MCL become compromised during the procedure. If additional constraint is required the surgeon can use the S-ROM femoral and insert. S-ROM femorals are used in less than 10% of knee revision procedures; but are present almost all the time.                DePuy Orthopaedics has identified the potential for holes to develop in the inner and outer flexible pouches that form the sterile barrier for S-ROM Noiles Rotating Hinge Femur with Pin devices. The outer carton and shrink wrap are intact. A package redesign is underway to resolve this issue. S-ROM Noiles Rotating Hinge Femur with Pin devices will remain in US Distributors inventory during the p

Elekta; Inc.          Mar-13-2014      XiO RPT System – XiO RPT SystemThe XiO RTP System is used to create treatment plans for any cancer patient for whom external beam radiation therapy or brachytherapy has been prescribed. The system will calculate and display; both on screen and in hard-copy; either two or three dimensional radiation dose distributions within a patient for a given treatment.                Dose and Monitor Unit values are not computed correctly when Elekta Motorized Wedges are used with Dynamic Conformal arcs.

Veridex; LLC       Mar-13-2014      Janssen Diagnostics; LLC – CELLTRACKS ANALYZER II (Product Code 9555)Product Usage:The CELLTRACKS ANALYZER II is a semi-automated fluorescence microscope; consisting of the analyzer; a dedicated computer with CELLTRACKS software; monitor; keyboard; mouse and uninterruptible power supply (UPS). The system also supports an optional Remote Review Workstation (RRW); which consists of a dedicated computer with CELLTRACKS software; monitor; keyboard and mouse. Use of this product requires training and should be used under the supervision of laboratory management. The CELLTRACKS ANALYZER II is for analysis of rare cells that are isolated from biological fluids including whole blood. It is used in conjunction with the CELLTRACKS AUTOPREP System; which automates and standardizes the sample preparation with specific reagent kits. An optional Remote Review Workstation is also available to provide the capability to review images and report results remotely.      Janssen Diagnostics; LLC received complaints of camera failures on the CELLTRACKS ANALYZER II.

Mar Cor Purification        Mar-13-2014      Mar Cor Purification Reverse Osmosis System – Mar Cor Purification CWP Reverse Osmosis System.  Models 101; 102; 104; and 106.              There exists a potential situation with the crimp connection at the pump head assembly.  The potential exists that the reverse osmosis pump head wiring could build resistance resulting in resistive heating of the surrounding components.  If this occurs; the pump head assembly may experience melting of the plastic components and potentially create smoke/fire and shut down of the unit.

GE Healthcare; LLC          Mar-13-2014      VG Hawkeye – GE Healthcare Varicam/VG and VG Hawkeye devices Product Usage: The intended use of the Quasar system is to perform general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body; using a variety of scanning modes supported by various acquisition typed and optional imaging features designed to enhance image quality in Oncology; Cardiology; Neurology and other clinical diagnostic imaging applications. The scanning modes include planar (Static; Multi-gated; Dynamic; Whole body scanning) and tomographic (SPECT; Gated SPECT; Whole body SPECT; Camera based PET). Acquisition types include single and multi-isotope/multi-peak frame/list mode single-photon and positron imaging. Optional imaging-enhancement features include assortment of collimators; gating by physiological signals; real-time automatic body contouring; and CT-based attenuation correction and functional anatomic mapping.      Potential safety issue related to unintended radial detector motion; which may occur during patient setup or at the end of a patient scan.  This failure mode has been observed on a single system; in which the detector moved to the home position and then slowly starting drifting inward toward the patient.  This generated both a visual and audio alert condition on both the console and the gantry.  N

GE Healthcare; LLC          Mar-13-2014      Helix – Elscint APEX Helix; dual-head; multi-purpose; Slip-Ring; digital gamma camera Product Usage: The intended use of the Quasar system is to perform general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body; using a variety of scanning modes supported by various acquisition typed and optional imaging features designed to enhance image quality in Oncology; Cardiology; Neurology and other clinical diagnostic imaging applications. The scanning modes include planar (Static; Multi-gated; Dynamic; Whole body scanning) and tomographic (SPECT; Gated SPECT; Whole body SPECT; Camera based PET). Acquisition types include single and multi-isotope/multi-peak frame/list mode single-photon and positron imaging. Optional imaging-enhancement features include assortment of collimators; gating by physiological signals; real-time automatic body contouring; and CT-based attenuation correction and functional anatomic mapping.               Potential safety issue related to unintended radial detector motion; which may occur during patient setup or at the end of a patient scan.  This failure mode has been observed on a single system; in which the detector moved to the home position and then slowly starting drifting inward toward the patient.  This generated both a visual and audio alert condition on both the console and the gantry.  N

GE Healthcare; LLC          Mar-13-2014      Infinia – GE Healthcare Infinia and  Infinia Hawkeye  Nuclear Medicine Systems.  For Dual-Head Variable Angle Gamma Camera; Hawkeye Option for Dual-Head Variable Angle Gamma Camera (this includes GE Quasar Nuclear Medicine Systems). Nuclear Medicine Systems Infinia devices Product Usage: The intended use of the Quasar system is to perform general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body; using a variety of scanning modes supported by various acquisition types and optional imaging features designed to enhance image quality in Oncology; Cardiology; Neurology and other clinical diagnostic imaging applications.                Potential safety issue related to unintended radial detector motion; which may occur during patient setup or at the end of a patient scan.  This failure mode has been observed on a single system; in which the detector moved to the home position and then slowly starting drifting inward toward the patient.  This generated both a visual and audio alert condition on both the console and the gantry.  N

Atricure Inc         Mar-14-2014      AtriCure Reusable Clip Applier – Reusable Clip Applier Manufactured by AtriCure; Inc.; 6217 Centre Park Drive; West Chester; OH 45069.The Reusable Clip Applier (Applier) is intended to be used to deploy the Gillinov-Cosgrove LAA Clip (Clip). The Gillinov-Cosgrove LAA Clip (Clip) is an implantable device used for occlusion of the left atrial appendage.             The firm was notified by a customer of a cracked spring in the handle of the RCD1 device.

Mar Cor Purification        Mar-14-2014      Mar Cor Purification Millenium HX Portable Reverse Osmosis System. – Mar Cor Purification Millenium HX Portable Reverse Osmosis System.  Model 3025975.  Product Usage:   Water Purification System is intended to be used as a dialysis accessory to produce water through reverse osmosis for use with hemodialysis equipment..       High inlet water pressure beyond specification and the solenoid valve does not meet application which could result in a delay in treatment.

DeRoyal Industries Inc   Mar-14-2014      DeRoyal(R) LIMB HOLDERS; COTTON ADJUSTABLE; UNIVERSAL; REF M2017; – DeRoyal(R) LIMB HOLDERS; COTTON ADJUSTABLE; UNIVERSAL; REF M2017Product Usage:  Limb holders are intended for mildly to moderate agitated or disoriented patients who disrupt medical treatment and/or cause harm to themselves and/or others    Moldy smell in product

Elekta; Inc.          Mar-14-2014      Medical Linear Accelerator – SL & SLi Series (Mod 15/18/20/25) Linear AcceleratorUsed for radiation therapy treatments of malignant neoplastics diseases.               Customers are resetting the default values outside recommended factory settings.

China Daheng Group Inc.              Mar-14-2014      Denlase: Diode Laser Therapy System and  Penlase Dental Laser Therapy System – Denlase: Diode Laser Therapy System and  Penlase:Dental Laser Therapy System surgical powered.Surgical powered Laser instruments.       Failure to provide calibration procedures to purchasers; as required by 21 CFR 1040.11(a)(2).  For example; the user manual did not contain calibration procedures for Denlase or Penlase Lasers

Biomet 3i; LLC    Mar-17-2014      BellaTek Zirconia Dental Abutment – Dental Abutment labeled in part: "4555 Riverside Drive Palm Beach Gardens; FL 33410 USA  1-800-342-5454***EDAZ ; EDAZx and ILDExxx***BellaTek Zirconia Abutment Position Number: XX Abutment; Pilier; Abutment; Abutment; Pilastro; Pilar***Rx only***Non-sterile; Sterilize prior to use.***Biomet 3i Dental Iberica S.L.***Biomet 3i Dental Abutments are intended for use as accessories to endosseous dental implants to support prostheses in edentulous or partially edentulous patients. These are intended for use to support single and multiple tooth prostheses.    Reports relating to Biomet 3i’s BellaTek Zirconia Dental Abutment fractures were received.

Alere San Diego; Inc.      Mar-17-2014      Drugs of Abuse Screen – Product Brand Name(s): Alere Triage TOX+MTD Drug Screen; Catalog Number 94400; Lots W56013B and W56035B.25 individually pouched devices in a labeled kit box.Indications for use: The Alere Triage TOX Drug Screen is a fluorescence immunoassay to be used with the Alere Triage Meters for the qualitative determination of the presence of drug and/or the major metabolites above the threshold concentrations of up to 10 distinct drug classes; including assays for acetaminophen/paracetamol; amphetamines; methamphetamines; barbiturates; benzodiazepines; cocaine; methadone; opiates; phencyclidine; THC and tricyclic antidepressants in urine. The acetaminophen/paracetamol assay will yield positive results when acetaminophen/paracetamol is ingested at or above therapeutic doses. This test provides only a preliminary result. Clinical consideration and professional judgment must be applied to any drug of abuse test result; particularly in evaluating a preliminary positive result. In order to obtain a confirmed analytical result; a more specific alternate chemical method is needed. Gas Chromatography/Mass Spectrometry (GC/MS); Liquid Chromatography/ Mass Spectrometry/ Mass Spectrometry (LC/MS/MS) and High Performance Liquid Chromatography (HPLC) are common confirmatory methods. A quantitative serum acetaminophen/paracetamol measurement is the common confirmatory method for preliminary positive acetaminophen/paracetamol results.     Alere San Diego; Inc. is initiating a recall of the Alere Triage TOX Drug Screen; Catalog Number 94400; Lots W56013B and W56035B because Alere’s investigation has shown that these lots have a frequency of false negative results for PCP (Phencyclidine) that is higher than the frequency shown in the package insert. If you have questions about previously reported results.

Exactech; Inc.    Mar-18-2014      Gibralt Polyaxial Screw – Gibralt Spine System Polyaxial ScrewIntended to promote fusion of the cervical spine; and the thoracic spine; (C3-T3); the Gibralt Spinal System is indicated for the following: DDD (neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; spinal stenosis; fracture; dislocation; failed previous fusion and/or tumors. The hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C3-T3) spine.    The products have been identified to contain springs which have been manufactured with type-304 stainless steel rather than the specified titanium alloy.

Siemens Medical Solutions USA; Inc        Mar-18-2014      Siemens syngo Dynamics – syngo Dynamics  Picture Archiving and Communication System (PACS).  Model numbers 10091804; 10091805; 10091806; 10091807; 10091673     Potential patient data mixup.  Improper error handling could allow for two different patients to be displayed in syngo Dynamics.  Images shown for one patient and reporting system shown for a different patient; leading to the potential for misdiagnosis.

Teleflex Medical               Mar-19-2014      The Rush Endobronchial Tube set – Rusch Brochopart and Rusch Brochopart WhiteThe Rush Endobronchial Tube set is indicated for uses commonly associated with oral endobronchial tubes; including; but not limited to; thoracic surgery; bronchospirometry; administration of endobronchial anesthesia; etc. The endobronchial tube allows ventilation and selective inflation or deflation of either lung.                The product may fail to achieve seal of right lung due to the cuff inflating to one side

Philips Medical Systems North America Inc.         Mar-19-2014      Philips HeartStart Home and OnSite (HS1) automated external defibrillators (AEDs) – Philips HeartStart Home and OnSite (HS1) automated external defibrillators (AEDs). Product Usage:  The models M5066A; M5067A; and M5068A are designed for use on a person in sudden cardiac arrest who is: -Unresponsive when shaken -Not breathing normally If in doubt; apply the pads. A training class in CPR/AED use is recommended for anyone who may use the HS1. If the person is an infant or child younger than eight years old or weighs less than 55 lbs (25 kg); use the special infant/child pads. If the child appears older/larger; use the adult pads. Do not delay treatment to determine the child s exact age or weight. If in doubt; use the adult pads.Models M5066A (for HS1 Onsite); M5067A (OnSite) ; and M5068A (for HS1 Home).               Philips is recalling HeartStart Home and OnSite (HS1) automated external defibrillators (AEDs) because one or both contact pins may be contaminated by residue from the soldering process. This contamination could prevent an adequate connection between the pads cartridge and the AED. If poor contact between the pads cartridge and AED occurs; the device may be unable to deliver therapy in an emergenc

Medical Information Technology; Inc.     Mar-19-2014      MEDITECH Microbiology – MEDITECH Microbiology; Client Server Releases 5.6; 5.65; 5.66; 5.67; 6.0; 6.05; 6.07; 6.1; 6.13 and 6.14.Integrates requisition; specimen processing; and patient information with data in the healthcare information system (HCIS).         Potential for erroneous result reporting.

Philips Medical Systems North America Inc.         Mar-19-2014      Philip’s HeartStart FR3 Automated External Defibrillator (AED) – Philips HeartStart FR3 Automated External Defibrillator (AED); models 861388 and 861389.The HeartStart FR3 is a battery powered automated external defibrillator (AED) designed for use by responders who have been trained in Basic Life Support (BLS); Advanced Life Support (ALS); or another physician-authorized emergency medical response program. The HeartStart FR3 is used to treat suspected victims of ventricular fibrillation (VF); the most common cause of sudden cardiac arrest (SCA); and certain ventricular tachycardia (VTs). Both models are used with disposable defibrillator pads applied to potential victims of SCA with the following symptoms: -Unresponsiveness -Absence of normal breathing If in doubt; apply the pads. The HeartStart FR3 is intended for adults and children over 55 pounds (25 kg) or 8 years old. Both models 861388 and 861389 are also intended for children under 55 pounds (25 kg) or 8 years old when used with the optional Infant/Child Key. If the Infant/Child Key is not available; or you are uncertain of the child’s age or weight; do not delay treatment.              Philip’s is recalling HeartStart FR3 Automated External Defibrillator (AED) because the Printed Circuit Board (PCB); which contains the circuitry that supplies energy to the device; could become separated from the electrical contact points that hold the board in place. In the event the PCB becomes separated from the electrical contact points; the AED may not be ready to deliver a shock in the even

Terumo Cardiovascular Systems Corporation      Mar-19-2014      Sarns Malleable Dual-stage Venous Return Cannulae – Sarns Malleable Dual-stage Venous Return Cannulae; 28/38 Fr with 1/2" connector; 14.5" (37 cm) longThe Sarns Malleable Dual-stage Venous Return Catheters and Sarns Dual-stage Venous Return Cannula are indicated for single-tube venous drainage from the right atrium and vena cava during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use.  During in-process inspection; Terumo Cardiovascular Systems (Terumo CVS) identified exposed basket wire on certain product lots of Sarns Malleable Dual-stage Venous Return Cannulae and Sarns Dual-stage Venous Return Cannulae.

Terumo Cardiovascular Systems Corporation      Mar-19-2014      Sarns Dual-stage Venous Return Cannulae – Sarns Dual-stage Venous Return Cannulae; 34/46 Fr with 1/2" flareThe Sarns Malleable Dual-stage Venous Return Catheters and Sarns Dual-stage Venous Return Cannula are indicated for single-tube venous drainage from the right atrium and vena cava during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use.    During in-process inspection; Terumo Cardiovascular Systems (Terumo CVS) identified exposed basket wire on certain product lots of Sarns Malleable Dual-stage Venous Return Cannulae and Sarns Dual-stage Venous Return Cannulae.

Terumo Cardiovascular Systems Corporation      Mar-19-2014      Sarns Dual-stage Venous Return Cannulae – Sarns Dual-stage Venous Return Cannulae; 32/40 Fr with 1/2" flareThe Sarns Malleable Dual-stage Venous Return Catheters and Sarns Dual-stage Venous Return Cannula are indicated for single-tube venous drainage from the right atrium and vena cava during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use.    During in-process inspection; Terumo Cardiovascular Systems (Terumo CVS) identified exposed basket wire on certain product lots of Sarns Malleable Dual-stage Venous Return Cannulae and Sarns Dual-stage Venous Return Cannulae.

Terumo Cardiovascular Systems Corporation      Mar-19-2014      Sarns Malleable Dual-stage Venous Return Cannulae – Sarns Malleable Dual-stage Venous Return Cannulae; 32/40 Fr with 1/2" connector; 15" (38 cm) longThe Sarns Malleable Dual-stage Venous Return Catheters and Sarns Dual-stage Venous Return Cannula are indicated for single-tube venous drainage from the right atrium and vena cava during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use.  During in-process inspection; Terumo Cardiovascular Systems (Terumo CVS) identified exposed basket wire on certain product lots of Sarns Malleable Dual-stage Venous Return Cannulae and Sarns Dual-stage Venous Return Cannulae.

Terumo Cardiovascular Systems Corporation      Mar-19-2014      Sarns Malleable Dual-stage Venous Return Cannulae – Sarns Malleable Dual-stage Venous Return Cannulae; 28/38 Fr with 1/2" connector; 14.5" (37 cm) long; with X CoatingThe Sarns Malleable Dual-stage Venous Return Catheters and Sarns Dual-stage Venous Return Cannula are indicated for single-tube venous drainage from the right atrium and vena cava during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use.               During in-process inspection; Terumo Cardiovascular Systems (Terumo CVS) identified exposed basket wire on certain product lots of Sarns Malleable Dual-stage Venous Return Cannulae and Sarns Dual-stage Venous Return Cannulae.

Terumo Cardiovascular Systems Corporation      Mar-19-2014      Sarns Malleable Dual-stage Venous Return Cannulae – Sarns Malleable Dual-stage Venous Return Cannulae; 34/46 Fr with 1/2" connector; 15" (38 cm) longThe Sarns Malleable Dual-stage Venous Return Catheters and Sarns Dual-stage Venous Return Cannula are indicated for single-tube venous drainage from the right atrium and vena cava during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use.  During in-process inspection; Terumo Cardiovascular Systems (Terumo CVS) identified exposed basket wire on certain product lots of Sarns Malleable Dual-stage Venous Return Cannulae and Sarns Dual-stage Venous Return Cannulae.

Terumo Cardiovascular Systems Corporation      Mar-19-2014      Sarns Malleable Dual-stage Venous Return Cannulae – Sarns Malleable Dual-stage Venous Return Cannulae; 34/46 Fr with 1/2" connector; 15" (38 cm) long; with X CoatingThe Sarns Malleable Dual-stage Venous Return Catheters and Sarns Dual-stage Venous Return Cannula are indicated for single-tube venous drainage from the right atrium and vena cava during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use.               During in-process inspection; Terumo Cardiovascular Systems (Terumo CVS) identified exposed basket wire on certain product lots of Sarns Malleable Dual-stage Venous Return Cannulae and Sarns Dual-stage Venous Return Cannulae.

Ortho-Clinical Diagnostics             Mar-19-2014      VITROS Chemistry Products White Reference Slides – VITROS Chemistry Products White Reference Slides; White Correction Factor Slide (WCF); DT Slides; 25 Slides; Part Number J02315; Made in USA by Ortho- Clinical Diagnostics; Inc. 100 Indigo Creek Drive; Rochester; NY 14626 — This product is a part/ tool used when performing the correction factors adjustment on the VITROS Chemistry Systems. It does not have a 510(k) number.Because the WCF slide is a part/ tool; and is not a device used for diagnostic testing; there is no Intended Use statement. The following summary is provided as a description/ explanation of the WCF slide. The WCF slide is a part/ tool used in the reflectometer correction factor adjustment procedure in order to optimize the optical calibration of the VITROS 250/350/5;1 FS/4600 Chemistry Systems and the VITROS 5600 Integrated              An incorrect assay value (0.3785) was printed on the product carton for the 460 nm wavelength (filter) that may cause a delay in the ability to obtain and report TBIL; Bu; Bc; and derived tests results.  The correct assay value is 0.8658.

Convatec Inc.     Mar-20-2014      Unomedical – SLC 2-way standard Lubricious Coated14ch/FR 5/10ml/ccProduct Usage:  Usage:Latex Lubricous Coated Foley Catheters The standard catheter essentially consists of a flexible lubricous coated latex tube which incorporates one major drainage lumen and one or two minor lumens constructed in the wall of the tube. One minor lumen is for inflating the retention balloon (available in 2-Way & 3-Way catheters). The second minor lumen (applicable for 3 Way catheters only) is used for bladder irrigation purposes.       The lumen of the Medline Sterile Foley Catheter was found to be blocked by excess lubricious coating material.

Stryker Instruments Div. of Stryker Corporation                Mar-20-2014      Hummer IV Microdebrider System – 2.5MM Aggressive BladeKnown as a Sinuscopic Shaver Blade; this device is composed of a metal cutter and plastic drive shaft that goes into a metal housing supported by a plastic hub. ENT Precision Cutter; Aggressive; ESSxlHUMMER 4; Rx OnlyIt is used for ENT procedures and functions by means of rotation when adapted to a handpiece and console. Through the rotation; the necessary tissue is resected as required by the user. The blade housing has an etching line guide that starts with a straight line and along with a scale from 1cm to 7cm in 1cm increments that serves the doctor as a guide by indicating how far the device is being introduced into the surgical area.                Stryker Instruments is voluntarily recalling the single use 2.5MM Aggressive Blade because the line on the affected part (P/N 5290-928-000; Lot #13280CG2) was a straight line without a number scale or logo. The line required for this part number includes a number scale that goes from 1cm 7cm.

Convatec Inc.     Mar-20-2014      Unomedical – SLC 3-way standard Lubricious Coated 20Ch/Fr 30 mL/ccProduct Usage:  Latex Lubricous Coated Foley Catheters The standard catheter essentially consists of a flexible lubricous coated latex tube which incorporates one major drainage lumen and one or two minor lumens constructed in the wall of the tube. One minor lumen is for inflating the retention balloon (available in 2-Way & 3-Way catheters). The second minor lumen (applicable for 3 Way catheters only) is used for bladder irrigation purposes.              The lumen of the Medline Sterile Foley Catheter was found to be blocked by excess lubricious coating material.

Convatec Inc.     Mar-20-2014      Medline – Medline Sterile Foley Catheter 14 fr 5 cc  12 pieces  model number DNYD11914Product Usage:Latex Lubricous Coated Foley Catheters The standard catheter essentially consists of a flexible lubricous coated latex tube which incorporates one major drainage lumen and one or two minor lumens constructed in the wall of the tube. One minor lumen is for inflating the retention balloon (available in 2-Way & 3-Way catheters). The second minor lumen (applicable for 3 Way catheters only) is used for bladder irrigation purposes.            The lumen of the Medline Sterile Foley Catheter was found to be blocked by excess lubricious coating material.

Remel Inc            Mar-20-2014      Oxoid Vancomycin susceptibility discs; 30 mcg. – Oxoid Vancomycin 30 mcg; each cartridge contains 50 susceptibility discs; CT0058B.  The firm name on the label is Oxoid Ltd.; Basingstoke; Hampshire; England.Used in the semi-quantitative agar diffusion test method for in-vitro susceptibility testing.      Some of the discs may not be impregnated with the antibiotic.

Convatec Inc.     Mar-20-2014      Medeco – Curion CuriStay Nelaton  CH – 14 2-W Hydrogel Coated (Latex) 5- 10 mLProduct Usage:  Latex Lubricous Coated Foley Catheters The standard catheter essentially consists of a flexible lubricous coated latex tube which incorporates one major drainage lumen and one or two minor lumens constructed in the wall of the tube. One minor lumen is for inflating the retention balloon (available in 2-Way & 3-Way catheters). The second minor lumen (applicable for 3 Way catheters only) is used for bladder irrigation purposes.       The lumen of the Medline Sterile Foley Catheter was found to be blocked by excess lubricious coating material.

Convatec Inc.     Mar-20-2014      JMS – JMS; Japan; 3 WAY; 20 FR 10 mL Product Usage:  Latex Lubricous Coated Foley Catheters The standard catheter essentially consists of a flexible lubricous coated latex tube which incorporates one major drainage lumen and one or two minor lumens constructed in the wall of the tube. One minor lumen is for inflating the retention balloon (available in 2-Way & 3-Way catheters). The second minor lumen (applicable for 3 Way catheters only) is used for bladder irrigation purposes.       The lumen of the Medline Sterile Foley Catheter was found to be blocked by excess lubricious coating material.

Convatec Inc.     Mar-20-2014      TORAY – ‘TORAY’ Hydrocoat Foley Catheter12 x104.00 mm Fr x mLProduct Usage: Latex Lubricous Coated Foley Catheters The standard catheter essentially consists of a flexible lubricous coated latex tube which incorporates one major drainage lumen and one or two minor lumens constructed in the wall of the tube. One minor lumen is for inflating the retention balloon (available in 2-Way & 3-Way catheters). The second minor lumen (applicable for 3 Way catheters only) is used for bladder irrigation purposes.              The lumen of the Medline Sterile Foley Catheter was found to be blocked by excess lubricious coating material.

Clarity Medical Systems Inc         Mar-20-2014      Halogen Lamp component  in RetCam 3 System – Halogen Lamp component  in RetCam 3 System – Clarity Medical Systems; Inc;Pleasanton; CA.General ophthalmic imaging including retinal; corneal and external imaging. Photo-documentation of pediatric ocular diseases including retinopathy of prematurity. Screening for Type-2 re-threshold retinopathy of prematurity or treatment requiring ROP.      One lot of Halogen lamps have the potential to fail sooner than the expected life of the lamp which could result in damage limited to the internal electrical components inside the RetCam 3 computer module.

Philips Medical Systems North America Inc.         Mar-20-2014      Philips Model EPIQ 5 Ultrasound System. – Philips Model EPIQ 5 Ultrasound System.  Intended for diagnostic ultrasound imaging and fluid flow analysis.Catalogue numbers 795200 / 795201 / 795202 / 795204 / 795205 / 795206EPIQ is intended for diagnostic ultrasound imaging and fluid flow analysis. The collection of Doppler velocity results values are used to assist in diagnosing the existence; location and severity of cardiac or vasculare stenosis.          A problem has been detected with Philips Model EPIQ 5 and 7 Ultrasound System.  The system will report incorrect Doppler velocities if you use High Pulse Repetition Frequency (HPRF) with multiple sample volume gates. While in High Pulse Repetition Frequency (HPRF) in Display Zoom  Velocity Scale using manual spectral Doppler trace; the velocities in the velocity results table may be overstated by

Philips Medical Systems North America Inc.         Mar-20-2014      Philips Model EPIQ 7 Ultrasound System. – Philips Model EPIQ 7 Ultrasound System.  Intended for diagnostic ultrasound imaging and fluid flow analysis.Catalogue numbers 795200 / 795201 / 795202 / 795204 / 795205 / 795206EPIQ is intended for diagnostic ultrasound imaging and fluid flow analysis. The collection of Doppler velocity results values are used to assist in diagnosing the existence; location and severity of cardiac or vasculare stenosis.          A problem has been detected with Philips Model EPIQ 5 and 7 Ultrasound System.  The system will report incorrect Doppler velocities if you use High Pulse Repetition Frequency (HPRF) with multiple sample volume gates. While in High Pulse Repetition Frequency (HPRF) in Display Zoom  Velocity Scale using manual spectral Doppler trace; the velocities in the velocity results table may be overstated b

Golden Technologies; Inc.            Mar-20-2014      Golden Buzzaround XL – Buzzaround XL scooters’ Product Usage:  mobility                Buzzaround XL scooters’ front to rear lockup can become unintentionally disengaged due to possible improper fit of the front alignment cup to the rear alignment screw.

Biomet; Inc.        Mar-20-2014      Intramedullary Bone Saw – Part 475620 Intramedullary Bone Saw CAM Assembly Size 12mm; A unique and exclusive clinical instrument used to correct leg length; or rotational discrepancies in the femur.                Incorrect labeling on specific lots of the Intramedullary Bone Saw.The Saw Blade Assembly was identified as CAM Assembly.

Biomet; Inc.        Mar-20-2014      Intramedullary Bone Saw – Part 475630; Intramedullary Bone Saw; Cam Assembly Size 14 mm; The Biomet Intramedullary Bone Saw is a unique and exclusive clinical instrument that is used to correct leg length; or rotational discrepancies in the femur.    Incorrect labeling on specific lots of the Intramedullary Bone Saw. The Saw Blade Assembly was identified as CAM Assembly.

Biomet; Inc.        Mar-20-2014      Intramedullary Bone Saw – Part 475625; Intramedullary Bone Saw; Cam Assembly Size 13 mm; The Biomet Intramedullary Bone Saw is a unique and exclusive clinical instrument that is used to correct leg length; or rotational discrepancies in the femur.    Incorrect labeling on specific lots of the Intramedullary Bone Saw. The Saw Blade Assembly was identified as CAM Assembly.

GE Healthcare; LLC          Mar-20-2014      GE Healthcare Optima CT580/Discovery CT590RT scanners – GE Healthcare Optima CT580/Discovery CT590RT scanners running software version 13BW16.3.The Discovery CT 590 RT and Optima CT 580 series of Computed Tomography systems are intended to produce cross-sectional images of the body by computer reconstruction of XRay transmission data taken at different angles and planes; including Axial; Cine; Helical (Volumetric); and Gated (Respiratory and Cardiac) acquisitions in patients of all ages. GE Healthcare has recently become aware of a potential safety issue due to a software issue associated with the Head Scan Protocols used on your Optima CT580 or Discovery CT590RT scanner.A potential hazardous situation may occur during a CT head scan causing a novel and rare artifact that may hide pathology. When using the head and large head SFOV; which applies the Iterative Bone Option (IBO)

Zimmer; Inc.       Mar-20-2014      Apollo" Knee System – Apollo" Knee System:APOLLO PATELLA SZ0 28MM R         A complaint was received for a discolored All Poly Tibia. Root cause analysis found that the discoloration was the result of free radical oxidation. Theoxidation process was advanced prematurely as a result of the machined component being stored in a transparent container exposed to artificiallight for six years prior to inert packaging and sterilization of the device.

Zimmer; Inc.       Mar-20-2014      Natural-Knee II Posterior Stabilized (P.S.) Condylar Tibial Inserts – Natural-Knee II Posterior Stabilized (P.S.) Condylar Tibial Inserts:N-K II CONS PS TIB INS SZN-K II CONS PS TIB INS SZN-K II CONS PS TIB INS SZN-K II CONS PS TIB INS SZN-K II CONS PS TIB INS SZN-K II CONS PS TIB INS SZN-K II CONS PS TIB INS SZN-K II CONS PS INS TIB SZN-K II CONS PS TIB INS SZN-K II CONS PS TIB INS SZN-K II CONS PS TIB INS SZN-K II CONS PS TIB INS SZN-K II CONS PS TIB INS SZN-K II CONS PS TIB INS SZ        A complaint was received for a discolored All Poly Tibia. Root cause analysis found that the discoloration was the result of free radical oxidation. Theoxidation process was advanced prematurely as a result of the machined component being stored in a transparent container exposed to artificiallight for six years prior to inert packaging and sterilization of the device.

Zimmer; Inc.       Mar-20-2014      Natural-Knee II System – Natural-Knee II SystemULTRA CONG INS LT SZA/9MMULTRA CONG INS LT SZA/13MULTRA CONG INS LT SZA/19MULTRA CONG INS RT SZA/9MMULTRA CONG INS RT SZA/11MULTRA CONG INS RT SZA/13MULTRA CONG INS RT SZA/19MULTRA CONG INS LT SZB/13MULTRA CONG INS LT SZB/16MULTRA CONG INS RT SZB/19MULTRA CONG INS RT SZB/22MNKII ROT PLTFM U/C INS; 9NKII ROT PLTFM U/C INS; 1NKII ROT PLTFM U/C INS; 1NKII ROT PLTFM U/C INS; 1NKII ROT PLTFM U/C INS; 1NKII ROT PLTFM U/C INS; 1NKII ROT PLTFM U/C INS; 1NKII ROT PLTFM U/C INS; 1NKII ROT PLTFM U/C INS; 1NKII ROT PLTFM U/C INS; 1NKII ROT PLTFM U/C INS; 1NKII ROT PLTFM U/C INS; 1NKII ROT PLTFM U/C INS; 1NKII ROT PLTFM U/C INS; 1ALL POLY CONG TIB LT SZ00ALL POLY CONG TIB LT SZ0/ALL POLY CONG TIB LT SZ0/ALL POLY CONG TIB RT SZ0/ALL POLY CONG TIB RT SZ0/ALL POLY CONG TIB LT SZ1/ALL POLY CONG TIB LT SZ1/ALL POLY CONG TIB RT SZ1/ALL POLY CONG TIB RT SZ1/ALL POLY CONG TIB RT SZ1/ALL POLY CONG TIB LT SZ2/ALL POLY CONG TIB LT SZ2/ALL POLY CONG TIB LT SZ2/ALL POLY CONG TIB LT SZ2/ALL POLY CONG TIB RT SZ2/ALL POLY CONG TIB RT SZ2/ALL POLY CONG TIB RT SZ2/ALL POLY CONG TIB LT SZ3/ALL POLY CONG TIB LT SZ3/ALL POLY CONG TIB LT SZ3/ALL POLY CONG TIB RT SZ3/ALL POLY CONG TIB RT SZ3/ALL POLY CONG TIB RT SZ3/ALL POLY CONG TIB LT SZ4/ALL POLY CONG TIB LT SZ4/ALL POLY CONG TIB RT SZ4/ALL POLY CONG TIB RT SZ4/ALL POLY CONG TIB RT SZ5/PS TIB INS RT SZ1/2 16MMPS TIB INS RT SZ1/2 19MMPS TIB INS LT SZ00/0 19MMPS TIB INS RT SZ00/0 11MMPS TIB INS RT SZ00/0 16MM           A complaint was received for a discolored All Poly Tibia. Root cause analysis found that the discoloration was the result of free radical oxidation. Theoxidation process was advanced prematurely as a result of the machined component being stored in a transparent container exposed to artificiallight for six years prior to inert packaging and sterilization of the device.

Zimmer; Inc.       Mar-20-2014      Natural-Knee/Apollo" Knee – Natural-Knee/Apollo" Knee:M/B PAT SZ0 NATURAL-KNEEM/B PAT SZ1 NATURAL-KNEEM/B PAT SZ2 NATURAL-KNEE    A complaint was received for a discolored All Poly Tibia. Root cause analysis found that the discoloration was the result of free radical oxidation. Theoxidation process was advanced prematurely as a result of the machined component being stored in a transparent container exposed to artificiallight for six years prior to inert packaging and sterilization of the device.

Zimmer; Inc.       Mar-20-2014      Natural-Knee II Constrained Knee System – Natural-Knee II Constrained Knee SystemNKII CCK TIB INS SZ00/0-LNKII CCK TIB INS SZ1/2-LFNKII CCK TIB INS SZ3-5 -LNKII CCK TIB INS SZ00/0-RNKII CCK TIB INS SZ3-5 -RNKII CCK TIB INS SZ1/2-LFNKII CCK TIB INS SZ3-5 -LNKII CCK TIB INS SZ00/0-RNKII CCK TIB INS SZ1/2-RTNKII CCK TIB INS SZ3-5 -RNKII CCK TIB INS SZ00/0-LNKII CCK TIB INS SZ1/2-LFNKII CCK TIB INS SZ3-5 -LNKII CCK TIB INS SZ00/0-RNKII CCK TIB INS SZ3-5 -RNKII CCK TIB INS SZ1/2-LFNKII CCK TIB INS SZ3-5 -LNKII CCK TIB INS SZ00/0-RNKII CCK TIB INS SZ3-5 -RNKII CCK TIB INS SZ00/0-LNKII CCK TIB INS SZ1/2-LFNKII CCK TIB INS SZ00/0-RNKII CCK TIB INS SZ1/2-RTNKII CCK TIB INS SZ1/2-LFNKII CCK TIB INS SZ3-5 -LNKII CCK TIB INS SZ00/0-RNKII CCK TIB INS SZ1/2-RTNKII CCK TIB INS SZ00/0-LNKII CCK TIB INS SZ00/0-R                A complaint was received for a discolored All Poly Tibia. Root cause analysis found that the discoloration was the result of free radical oxidation. Theoxidation process was advanced prematurely as a result of the machined component being stored in a transparent container exposed to artificiallight for six years prior to inert packaging and sterilization of the device.

Zimmer; Inc.       Mar-20-2014      Natural-Knee II System – Natural-Knee II System:POLY ULTRA TIB LT SZ00/9MPOLY ULTRA TIB LT SZ0/9MMPOLY ULTRA TIB LT SZ0/19MPOLY ULTRA TIB RT SZ0/13MPOLY ULTRA TIB RT SZ0/16MALL POLY ULTRA TIB LT SZ1ALL POLY ULTRA TIB RT SZ1ALL POLY ULTRA TIB LT SZ2ALL POLY ULTRA TIB LT SZ2ALL POLY ULTRA TIB RT SZ2ALL POLY ULTRA TIB LT SZ3ALL POLY ULTRA TIB RT SZ3ALL POLY ULTRA TIB RT SZ5  A complaint was received for a discolored All Poly Tibia. Root cause analysis found that the discoloration was the result of free radical oxidation. Theoxidation process was advanced prematurely as a result of the machined component being stored in a transparent container exposed to artificiallight for six years prior to inert packaging and sterilization of the device.

Zimmer; Inc.       Mar-20-2014      Apollo" Knee System – Apollo" Knee System:PS TIB INS SZ0/16MM APOLLPS TIB INS SZ0/19MM APOLLPS TIB INS SZ0/22MM APOLLPS TIB INS SZ1/16MM APOLLPS TIB INS SZ2/16M APOLLOPS TIB INS SZ2/22MM APOLLPS TIB INS SZ3/16MM APOLLPS TIB INS SZ3/19MM APOLLPS TIB INS SZ4/9MM APOLLOPS TIB INS SZ4/11MM APOLLPS TIB INS SZ4/13MM APOLLPS TIB INS SZ4/16MM APOLLPS TIB INS SZ4/19MM APOLLPS TIB INS SZ4/22MM APOLLPS TIB INS SZ5/9MM APOLLOPS TIB INS SZ5/19MM APOLL       A complaint was received for a discolored All Poly Tibia. Root cause analysis found that the discoloration was the result of free radical oxidation. Theoxidation process was advanced prematurely as a result of the machined component being stored in a transparent container exposed to artificiallight for six years prior to inert packaging and sterilization of the device.

Zimmer; Inc.       Mar-20-2014      Natural-Knee II Unicompartmental Knee System – Natural-Knee II Unicompartmental Knee System:UNI ALL-POLY TIB SZ 1-7mmUNI ALL-POLY TIB SZ 1-9mm               A complaint was received for a discolored All Poly Tibia. Root cause analysis found that the discoloration was the result of free radical oxidation. Theoxidation process was advanced prematurely as a result of the machined component being stored in a transparent container exposed to artificiallight for six years prior to inert packaging and sterilization of the device.

Zimmer; Inc.       Mar-20-2014      Apollo Knee Tibial Baseplate/Knee Tibial Insert – Apollo Knee Tibial Baseplate/Knee Tibial Insert:CONG TIB INS SZ0/19MM APOCONG TIB INS SZ0/22MM APOCONG TIB INS SZ1/9MM APOLCONG TIB INS SZ1/11MM APOCONG TIB INS SZ1/19MM APOCONG TIB INS SZ2/13MM APOCONG TIB INS SZ2/19MM APOCONG TIB INS SZ3/9MM APOLCONG TIB INS SZ3/13MM APO        A complaint was received for a discolored All Poly Tibia. Root cause analysis found that the discoloration was the result of free radical oxidation. Theoxidation process was advanced prematurely as a result of the machined component being stored in a transparent container exposed to artificiallight for six years prior to inert packaging and sterilization of the device.

Zimmer; Inc.       Mar-20-2014      Natural-Knee Congruent Tibial Insert with Screw – Natural-Knee Congruent Tibial Insert with Screw:SF-CON TIB INS LT SZ1/2 1SF-CON TIB INS RT SZ1/2 9SF-CON TIB INS RT SZ3/4/5          A complaint was received for a discolored All Poly Tibia. Root cause analysis found that the discoloration was the result of free radical oxidation. Theoxidation process was advanced prematurely as a result of the machined component being stored in a transparent container exposed to artificiallight for six years prior to inert packaging and sterilization of the device.

Zimmer; Inc.       Mar-20-2014      MOST Options" System – MOST Options" System (MOST)HINGED TIB INS SZ 1 16MMHINGED TIB INS SZ 4 6MM MHINGED TIB INS SZ 4 9MM MHINGED TIB INS SZ 4 16MMMOST PROX TIB INS 6MM    A complaint was received for a discolored All Poly Tibia. Root cause analysis found that the discoloration was the result of free radical oxidation. Theoxidation process was advanced prematurely as a result of the machined component being stored in a transparent container exposed to artificiallight for six years prior to inert packaging and sterilization of the device.

Zimmer; Inc.       Mar-20-2014      Natural-Knee II System – Natural-KneeN-K II DOMED ALL-POLY PAT; SZ0N-K II DOMED ALL-POLY PAT; SZ1   A complaint was received for a discolored All Poly Tibia. Root cause analysis found that the discoloration was the result of free radical oxidation. Theoxidation process was advanced prematurely as a result of the machined component being stored in a transparent container exposed to artificiallight for six years prior to inert packaging and sterilization of the device.

Zimmer; Inc.       Mar-20-2014      Apollo" Revision/Constrained Knee System – Apollo" Revision/Constrained Knee System:SZ0-16MM AK CCK TIB INSERSZ1-11MM AK CCK TIB INSERSZ1-16MM AK CCK TIB INSERSZ1-22MM AK CCK TIB INSERSZ1-30MM AK CCK TIB INSERSZ2-11MM AK CCK TIB INSERSZ2-13MM AK CCK TIB INSERSZ2-16MM AK CCK TIB INSERSZ2-22MM AK CCK TIB INSERSZ2-30MM AK CCK TIB INSERSZ3-16MM AK CCK TIB INSERSZ3-22MM AK CCK TIB INSERSZ3-25MM AK CCK TIB INSERSZ4-13MM AK CCK TIB INSERSZ4-16MM AK CCK TIB INSERSZ5-11MM AK CCK TIB INSER                A complaint was received for a discolored All Poly Tibia. Root cause analysis found that the discoloration was the result of free radical oxidation. Theoxidation process was advanced prematurely as a result of the machined component being stored in a transparent container exposed to artificiallight for six years prior to inert packaging and sterilization of the device.

Zimmer; Inc.       Mar-20-2014      Natural-Knee II – Unicompartmental Knee Prosthesis – Natural-Knee II – Unicompartmental Knee Prosthesis:CONG TIB INS SZ1/2 9MM UNCONG TIB INS SZ1/2 11MM UCONG TIB INS SZ1/2 13MM UCONG TIB INS SZ3/4 9MM UNCONG TIB INS SZ3/4 11MM UCONG TIB INS SZ3/4 13MM UCONG TIB INS SZ 5/6 9MM UCONG TIB INS SZ5/6 11MM UCONG TIB INS SZ5/6 13MM U   A complaint was received for a discolored All Poly Tibia. Root cause analysis found that the discoloration was the result of free radical oxidation. Theoxidation process was advanced prematurely as a result of the machined component being stored in a transparent container exposed to artificiallight for six years prior to inert packaging and sterilization of the device.

Zimmer; Inc.       Mar-20-2014      Gender Solutions" Natural-Knee Flex System – Gender Solutions" Natural-Knee Flex System:N-K FLEX MBACK SZ 0 PATN-K FLEX MBACK SZ 1 PATN-K FLEX MBACK SZ 2 PAT   A complaint was received for a discolored All Poly Tibia. Root cause analysis found that the discoloration was the result of free radical oxidation. Theoxidation process was advanced prematurely as a result of the machined component being stored in a transparent container exposed to artificiallight for six years prior to inert packaging and sterilization of the device.

Bock;Otto;Orthopedic Ind;Inc    Mar-21-2014      Aerial Wheelchair Cushion – Otto Bock Aerial and Aerial Active Wheelchair Cushions.  Material numbers:  SK757 476C00=SK701; 476C00=SK702; 476C00=SK703; 476C00=SK704; 476C00=SK705; 476C00=SK706; 476C00=SK707;   The following material numbers were not distributed within the US:  476C00=SK751; 476C00=SK752; 476C00=SK753; 476C00=SK754; 476C00=SK755; 476C00=SK756; 476C00= SK757.    Otto Bock is recalling all Aerial and Aerial Active Wheelchair Cushions from specific material numbers.  During internal testing; it was discovered that there is a small risk of flammability to the cushion after it has been washed at high temperatures.  The cushions should either be returned to Otto Bock or destroyed.

AMS Diagnostics; LLC      Mar-21-2014      AMS URIC ACID – AMS URIC ACID For the In vitro quantitative determination of Uric Acid in serumQuantitative determination of Uric Acid in serum. Marketing the devices outside 510(k) requirements

AMS Diagnostics; LLC      Mar-21-2014      AMS AST – AMS AST For the In vitro quantitative determination of AST in serum Quantitative determination of AST in serum.      Marketing the devices outside 510(k) requirements

AMS Diagnostics; LLC      Mar-21-2014      AMS BUN UREA NITROGEN – AMS BUN UREA NITROGEN For the In vitro quantitative determination of Urea Nitrogen in serumQuantitative determination of Bun in serum.         Marketing the devices outside 510(k) requirements

Mevion Medical Systems; Inc.    Mar-22-2014      MEVION – MEVION S250; System; Radiation Therapy; Charged-Particle; Medical used for Proton Radiation TherapyProduct Usage:  Proton Radiation Therapy     Geometric positioning error can occur after a rotational correction has been applied to one or more treatment fields

Siemens Medical Solutions USA; Inc        Mar-22-2014      Siemens – AXIOM Artis SystemsProduct usage:  Artis zee is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including; but not limited to; pediatric and obese patients.           Certain units of the AXIOM Artis Systems are using a flat detector cooling unit with inappropriate connectors that may possibly leak; causing a system failure and possible drop out of the gantry system.

Velocity Medical Solutions; LLC  Mar-25-2014      DICOM – DICOM Export Format for Sum Dose with Velocity v3.0.0.A stand-alone software product that provides the oncology care specialists (physicians; physicists; dosimetrists; etc.) a means for comparison of medical imaging data from multiple DICOM conformant imaging modality sources. It allows the display; annotating; volume rendering; registration and fusing of medical images as an aid during use by diagnostic radiology; oncology; radiation therapy planning and other medical specialties.         An anomaly was detected such that; under certain conditions; a summed dose created by Velocity replaces the calculated dose from an approved plan in Eclipse when importing the dose from Velocity.

Spacelabs Healthcare; Llc              Mar-25-2014      Spacelabs Healthcare G2 Clinical Access CD – Spacelabs Healthcare G2 Clinical Access Mislabeled CDs for PN: 063-1829-11 Rev A and Update Kit; PN: 040-1565-10.Used for installing ICS G2 Clinical Access software onto hospital personal computers.        Spacelabs has voluntarily recalled G2 Clinical Access Software CD because the programs installed on the Clinical Access CD are incorrect and it will prevent the customer frominstalling Clinical Access.

Teleflex Medical               Mar-25-2014      Weck – Weck Vista"; Universal Laparoscopic Port; Size 5/10mmx100mm; Product Usage:  An endoscope and accessories is a device used to provide access; illumination; and allow observation or manipulation of body cavities; hollow organs; and canals.             Complaints were received of leakage of insufflation gas through the device; which can cause difficulty or delay in the completion of laparoscopic surgical procedures.

Teleflex Medical               Mar-25-2014      Weck – 5/10/12 Weck Vista" Universal Balloon Open Access Port Standard Length (70mm); Product Usage:  An endoscope and accessories is a device used to provide access; illumination; and allow observation or manipulation of body cavities; hollow organs; and canals.               Complaints were received of leakage of insufflation gas through the device; which can cause difficulty or delay in the completion of laparoscopic surgical procedures.

Teleflex Medical               Mar-25-2014      Weck – Weck Vista" Universal Laparoscopic Port; Size 5/10/12mmx100mm; Product Usage:  An endoscope and accessories is a device used to provide access; illumination; and allow observation or manipulation of body cavities; hollow organs; and canals.             Complaints were received of leakage of insufflation gas through the device; which can cause difficulty or delay in the completion of laparoscopic surgical procedures.

Teleflex Medical               Mar-25-2014      Weck – 5/10 mm Weck; Vista" Optical Bladeless Laparoscopic Access Port; Product Usage:  An endoscope and accessories is a device used to provide access; illumination; and allow observation or manipulation of body cavities; hollow organs; and canals.             Complaints were received of leakage of insufflation gas through the device; which can cause difficulty or delay in the completion of laparoscopic surgical procedures.

Teleflex Medical               Mar-25-2014      Weck – 5/10/12 mm Weck Vista" Optical Bladeless Laparoscopic Access Port; Product Usage:  An endoscope and accessories is a device used to provide access; illumination; and allow observation or manipulation of body cavities; hollow organs; and canals.             Complaints were received of leakage of insufflation gas through the device; which can cause difficulty or delay in the completion of laparoscopic surgical procedures.

Teleflex Medical               Mar-25-2014      Weck – 5/10/12 Weck Vista" Universal Balloon Open Access Port Long Length (100mm);Product Usage:  An endoscope and accessories is a device used to provide access; illumination; and allow observation or manipulation of body cavities; hollow organs; and canals.               Complaints were received of leakage of insufflation gas through the device; which can cause difficulty or delay in the completion of laparoscopic surgical procedures.

Teleflex Medical               Mar-25-2014      Weck – 10mm Weck Vista" Cannula-only; Teleflex Medical; Product Usage:  An endoscope and accessories is a device used to provide access; illumination; and allow observation or manipulation of body cavities; hollow organs; and canals.          Complaints were received of leakage of insufflation gas through the device; which can cause difficulty or delay in the completion of laparoscopic surgical procedures.

Teleflex Medical               Mar-25-2014      Weck – 5/10 Weck Vista" Universal Balloon Open Access Port – Long Length (100mm); Product Usage:  An endoscope and accessories is a device used to provide access; illumination; and allow observation or manipulation of body cavities; hollow organs; and canals.               Complaints were received of leakage of insufflation gas through the device; which can cause difficulty or delay in the completion of laparoscopic surgical procedures.

Teleflex Medical               Mar-25-2014      Weck – Weck Vista" Universal Laparoscopic Port; Size 5/10/12mmx125mm; Product Usage:  An endoscope and accessories is a device used to provide access; illumination; and allow observation or manipulation of body cavities; hollow organs; and canals.             Complaints were received of leakage of insufflation gas through the device; which can cause difficulty or delay in the completion of laparoscopic surgical procedures.

Teleflex Medical               Mar-25-2014      Weck – 5/10 mm Weck; Vista" Universal Cannula; Teleflex Medical; Product Usage:  An endoscope and accessories is a device used to provide access; illumination; and allow observation or manipulation of body cavities; hollow organs; and canals.              Complaints were received of leakage of insufflation gas through the device; which can cause difficulty or delay in the completion of laparoscopic surgical procedures.

Teleflex Medical               Mar-25-2014      Weck – 12mm Weck Vista" Cannula-only; Teleflex Medical; Product Usage:  An endoscope and accessories is a device used to provide access; illumination; and allow observation or manipulation of body cavities; hollow organs; and canals.          Complaints were received of leakage of insufflation gas through the device; which can cause difficulty or delay in the completion of laparoscopic surgical procedures.

Teleflex Medical               Mar-25-2014      Weck – 5/10 Weck Vista" Universal Balloon Open Access Port – Standard Length (70mm); Product Usage:  An endoscope and accessories is a device used to provide access; illumination; and allow observation or manipulation of body cavities; hollow organs; and canals.               Complaints were received of leakage of insufflation gas through the device; which can cause difficulty or delay in the completion of laparoscopic surgical procedures.

Teleflex Medical               Mar-25-2014      Weck – 5/10 Weck Vista" Universal Balloon Open Access Port Short Length (53mm); Product Usage:  An endoscope and accessories is a device used to provide access; illumination; and allow observation or manipulation of body cavities; hollow organs; and canals.               Complaints were received of leakage of insufflation gas through the device; which can cause difficulty or delay in the completion of laparoscopic surgical procedures.

Synthes; Inc.      Mar-25-2014      Synthes 2.7mm LCP Ulna Osteotomy System – Drill Template and the Saw Guide for the Ulna Osteotomy System.Intended for fixation of fractures; osteotomies; nonunions; replantations; and fusions of small bones and small bone fragments; including osteopenic bone in the ulna.              The Drill Template and the Saw Guide for the Ulna Osteotomy System may exhibit jamming; bending; or breaking of the screw connecting the Saw Guide to the Drill Template or jamming; bending; or breaking of the K-wire during fixation of the Drill Template.

Teleflex Medical               Mar-25-2014      Weck – 5/10/12MM X 100MM Weck Vista" UNIVERSAL CONE OPEN ACCESS; Product Usage:  An endoscope and accessories is a device used to provide access; illumination; and allow observation or manipulation of body cavities; hollow organs; and canals.             Complaints were received of leakage of insufflation gas through the device; which can cause difficulty or delay in the completion of laparoscopic surgical procedures.

Teleflex Medical               Mar-25-2014      Weck – 5/10/12 mm Weck Vista" Universal Cannula;Product Usage:  An endoscope and accessories is a device used to provide access; illumination; and allow observation or manipulation of body cavities; hollow organs; and canals.           Complaints were received of leakage of insufflation gas through the device; which can cause difficulty or delay in the completion of laparoscopic surgical procedures.

Trivascular; Inc  Mar-26-2014      Ovation Prime Abdominal Stent Graft System – Ovation Prime Abdominal Stent Graft System;Manufacturer:TriVascular; Inc. 3910 Brickway Blvd. Santa Rosa; CA 95403The TriVascular Ovation Prime Abdominal Stent Graft System is an endovascular device delivered via a small diameter catheter to treat abdominal aortic aneurysms (AAAs). The stent graft is designed to reline the diseased vasculature; providing an endovascular blood conduit for isolating the aneurysm from the high pressure flow of blood; thereby reducing the risk of rupture. The stent graft is a modular configuration comprised of an aortic body section; iliac limbs; and iliac extensions as required.    Communication to European physician users of the Ovation Prime Abdominal Stent Graft system to notify them of changes to Instructions for Use.

Teleflex Medical               Mar-26-2014      Suture; Non-absorbable; Synthetic; Polyamide – Suture; Non-absorbable; Synthetic; Polyamide; Sterile; Rx only; Product Usage:Non-absorbable polyamide surgical suture is a non-absorbable; sterile; flexible thread prepared from long-chain aliphatic polymers Nylon 6 and Nylon 6;6 and is indicated for use in soft tissue approximation. The products are being recalled because they did not meet minimum needle attachment strength requirements.

Teleflex Medical               Mar-26-2014      Suture; nonabsorbable; synthetic; polyethylene – Sutures; Non-absorbable; Synthetic; Polypropylene; Sterile; Rx only; Product Usage:Non-absorbable polypropylene surgical suture is a monofilament; Non-absorbable; sterile; flexible thread prepared from long-chain polyolefin polymer known as polypropylene and is indicated for use in soft tissue approximation.   The products are being recalled because they did not meet minimum needle attachment strength requirements.

Teleflex Medical               Mar-26-2014      Sutures; Non-absorbable; Silk; Sterile – Sutures; Non-absorbable; Silk; Sterile; Rx only; Product Usage:  Natural non-absorbable silk surgical suture is a non-absorbable; sterile; flexible multifilament thread composed of an organic protein called fibroin. This protein is derived from the domesticated species Bombyx mori (B. mori) of the family Bombycidae. Natural non-absorbable silk surgical suture is indicated for use in soft tissue approximation. Natural non-absorbable silk surgical suture meets the United States Pharmacopeia (U.S.P.) monograph requirements for Non-absorbable Surgical Suture (class I). Natural non-absorbable silk surgical suture may be braided or twisted; it may be provided uncoated or coated; and it may be undyed or dyed with an FDA listed color additive.   The products are being recalled because they did not meet minimum needle attachment strength requirements.

Teleflex Medical               Mar-26-2014      Sutures; Absorbable; Synthetic; Polyglycolic Acid. – Sutures; Absorbable; Synthetic; Polyglycolic Acid; Sterile; Rx only; Product Usage:  Non-absorbable polypropylene surgical suture is a monofilament; Non-absorbable; sterile; flexible thread prepared from long-chain polyolefin polymer known as polypropylene and is indicated for use in soft tissue approximation.       The products are being recalled because they did not meet minimum needle attachment strength requirements.

Teleflex Medical               Mar-26-2014      Suture; nonabsorbable; synthetic; polyethylene. – Sutures; Non-absorbable; Synthetic; Polyethylene; Sterile; Rx only; Product Usage:  Non-absorbable poly(ethylene terephthalate) surgical suture is a multifilament; non-absorbable; sterile; flexible thread prepared from fibers of high molecular weight; long-chain; linear polyesters having recurrent aromatic rings as an integral component and is indicated for use in soft tissue approximation.                The products are being recalled because they did not meet minimum needle attachment strength requirements.

Teleflex Medical               Mar-26-2014      Sutures; Non-absorbable; Steel; Monofilament and Multifilament; Sterile – Sutures; Non-absorbable; Steel; Monofilament and Multifilament; Sterile; Rx only; Product Usage:A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys; such as cobalt-chromium-molybdenum and stainless steel; and that may be smooth on the outside; fully or partially threaded; straight or Ushaped; and may be either blunt pointed; sharp pointed; or have a formed; slotted head on the end. It may be used for fixation of bone fractures; for bone reconstructions; as a guide pin for insertion of other implants; or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.          The products are being recalled because they did not meet minimum needle attachment strength requirements.

Abbott Point Of Care Inc.             Mar-27-2014      i-STAT G3+ Cartridge – i-STAT G3+ CartridgepH; pCO2 and pO2 measurements are used in the diagnosis; monitoring and treatment of respiratory disturbances and metabolic and respiratory based acid-based disturbances.         Abbott Point of Care has determined that some individual patient results generated with thei-STAT G3+ cartridge lot N13183 have the potential to exhibit incorrectly elevated PCO2 anddepressed pH results.

Medtronic Vascular; Inc.               Mar-27-2014      FIBERNET Embolic Protection System:Recommended Vessel Diameter 3.5 0 5.0 mm – FIBERNET Embolic Protection System:Recommended Vessel Diameter 3.5 0 5.0 mm; Maximum Guidewire Diameter: 0.014 in ( 0.36 mm)Rx only; Sterile;Manufactured in:Invatec S.P.A.; 25030 Roncadelle; Italy;Manufacturer:Medtronic Inc.Minneapolis; MN 55432.The FiberNet Embolic Protection System is indicated for use as a guidewire and emboli protection system to capture and remove embolic material (thrombus/debris) produced while performing percutaneous transluminal interventional procedures in carotid arteries in high surgical risk patients with reference vessel diameters of 3.5 mm to 7.0 mm.            Medtronic is recalling a specific subset of lot numbers of the FIBERNET Embolic Protection System (EPS) where the yellow polyimide tube on the FIBERNET EPS was not removed from the FIBERNET EPS during the manufacturing process and subsequently may remain on the FIBERNET EPS.

Medtronic Vascular; Inc.               Mar-27-2014      FIBERNET Embolic Protection System: Recommended Vessel Diameter 5.0 -6.0 mm – FIBERNET Embolic Protection System:Recommended Vessel Diameter 5.0 -6.0 mm; Maximum Guidewire Diameter:0.014 in (0.36mm)Rx only; Sterile;Manufactured in:Invatec S.P.A.; 25030 Roncadelle; Italy;Manufacturer:Medtronic Inc.Minneapolis; MN 55432.The FiberNet Embolic Protection System is indicated for use as a guidewire and emboli protection system to capture and remove embolic material (thrombus/debris) produced while performing percutaneous transluminal interventional procedures in carotid arteries in high surgical risk patients with reference vessel diameters of 3.5 mm to 7.0 mm.            Medtronic is recalling a specific subset of lot numbers of the FIBERNET Embolic Protection System (EPS) where the yellow polyimide tube on the FIBERNET EPS was not removed from the FIBERNET EPS during the manufacturing process and subsequently may remain on the FIBERNET EPS.

Medtronic Vascular; Inc.               Mar-27-2014      FIBERNET Embolic Protection System: Recommended Vessel Diameter 6.0 -7.0 mm – FIBERNET Embolic Protection System:Recommended Vessel Diameter 6.0 -7.0 mm; Maximum Guidewire Diameter:0.014 in (0.36mm)Rx only; Sterile;Manufactured in:Invatec S.P.A.; 25030 Roncadelle; Italy;Manufacturer:Medtronic Inc.Minneapolis; MN 55432.The FiberNet Embolic Protection System is indicated for use as a guidewire and emboli protection system to capture and remove embolic material (thrombus/debris) produced while performing percutaneous transluminal interventional procedures in carotid arteries in high surgical risk patients with reference vessel diameters of 3.5 mm to 7.0 mm.            Medtronic is recalling a specific subset of lot numbers of the FIBERNET Embolic Protection System (EPS) where the yellow polyimide tube on the FIBERNET EPS was not removed from the FIBERNET EPS during the manufacturing process and subsequently may remain on the FIBERNET EPS.

Biocardia; Inc.    Mar-27-2014      Catheter Introducer – Morph AccessPro Steerable Introducer;6F Introducer; 90 cm working length:Single use only.BioCardia; Inc.San Carlos; CA 94070BioCardia Morph AccessPro is intended to provide a pathway through medical instruments cush as balloon dilation catheters; guidewires or other therapeutic devices that may be introduced into the peripheral vasculature.         Firm discovered the potential for particulates in the inner lumen of Morph Access Pro Steerable Introducer; which could result in am embolic event.

Siemens Medical Solutions USA; Inc        Mar-27-2014      Siemens – Siemens Artis Q and Artis Q biplane systemsProduct Usage:  Interventional Fluoroscopic X-ray             There exists the possibility that during clinical operation; a breakdown of the x-ray tube could result in loss of x-ray imaging for the Artis Q and Artis Q biplane systems with a flat detector as 40 HDR (large 30×40).

Biocardia; Inc.    Mar-27-2014      Catheter Introducer – Morph AccessPro Steerable Introducer;6F Introducer; 45 cm working lengthSingle use only.BioCardia; Inc.San Carlos; CA 94070BioCardia Morph AccessPro is intended to provide a pathway through medical instruments cush as balloon dilation catheters; guidewires or other therapeutic devices that may be introduced into the peripheral vasculature.         Firm discovered the potential for particulates in the inner lumen of Morph Access Pro Steerable Introducer; which could result in am embolic event.

Bard Access Systems      Mar-27-2014      PowerPort Slim Implantable Port – PowerPort Slim Implantable Port; indicated for patient therapies requiring repeated access to the vascular system.  Product Codes: 1716000; 1716070   Bard Access Systems; Inc. has notified customers of a labeling discrepancy involving PowerPort Slim Implantable Port 1716000; 1716070 in which the label states that the implantable port contains silicone suture plugs; however approximately 23% of the units contained in the affected lots have a PowerPort Slim titanium implantable port without silicone suture plugs.

Bio-Rad Laboratories; Inc.            Mar-27-2014      D-10" Hemoglobin Testing System – D-10" Hemoglobin Testing System;Model number: 220-0220 Manufactured by:Bio-Rad Laboratories; Inc.4000 Alfred Nobel DriveHercules; CA 94545The D-10 Hemoglobin Testing System is a single module designed for hemoglobin analysis in mid-volume laboratories. The D-10 is a fully integrated system for sample dilution; processing and analysis of hemoglobin; designed for use with specific Bio-Rad reagent kits. The D-10 incorporates the use of a dedicated software system for instrument control; data collection and analysis.  On a rare occasion the D-10 software might generate an extra result by duplicating the result form the previous sample and the Sample ID/Injection number from the next sample.

RAYSEARCH LABORATORIES AB Mar-28-2014      RayStation – Radiation Therapy Treatment Planning SystemRayStation is a software system designed for treatment planning and analysis of radiation therapy. The treatment plans provide treatment unit set-up parameters and estimates of dose distributions expected during the proposed treatment; and may be used to administer treatments after review and approval by the intended user.         RaySearch Laboratories has recalled their Radiation Therapy Treatment Planning System Stand-alone software due to program errors.

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