BEUDAMED
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    West Nile Virus IgM Capture ELISA The Panbio West Nile Virus IgM Capture ELISA is for the qualitative presumptive detection of IgM antibodies to West Nile virus in serum as an aid in the clinical laboratory diagnosis of West Nile virus infection in patients with clinical symptoms consistent with encephalitis/meningitis. Positive results must be confirmed by plaque reduction neutralization test (PRNT), or by using the current Centers for Disease Control and Prevention (CDC) guidelines for diagnosis of this disease. Assay performance characteristics have not been established for testing cord blood, neonate, prenatal screening, general population screening without symptoms of meningoencephalitis or automated instruments. The user is responsible for establishing these assay performance characteristics.

    FDA Recall
    Terminated ·Inverness Medical·Product code NOP·October 8, 2008

    Transport Stryker Medical Stretchers Model 748 Intended to transport patients in a horizontal position.

    FDA Recall
    Terminated ·Stryker Medical Division of Stryker Corporation·Product code FPO·July 19, 2011

    Prime 5th Wheel Stryker Medical Stretchers Model 1105 Intended to transport patients in a horizontal position.

    FDA Recall
    Terminated ·Stryker Medical Division of Stryker Corporation·Product code FPO·July 19, 2011

    Eye Surgery Stryker Medical Stretchers Model 1089 Intended to transport patients in a horizontal position.

    FDA Recall
    Terminated ·Stryker Medical Division of Stryker Corporation·Product code FPO·July 19, 2011

    Sechrist Stryker Medical Stretchers Model 742 Intended to transport patients in a horizontal position.

    FDA Recall
    Terminated ·Stryker Medical Division of Stryker Corporation·Product code FPO·July 19, 2011

    Trauma Stryker Medical Stretchers Model 1037 Intended to transport patients in a horizontal position.

    FDA Recall
    Terminated ·Stryker Medical Division of Stryker Corporation·Product code FPO·July 19, 2011

    UCG Beta Slide Monoclonal II is a latex agglutination inhibition slide test for the detection of hCG in urine. This test is used for the diagnosis of pregnancy.

    FDA Recall
    Terminated ·Inverness Medical Professional Diagnostics·Product code LCX·February 12, 2010

    UCG Slide Test; Rapid latex agglutination inhibition slide test for the detection of hCG in urine. Used in the diagnosis of pregnancy.

    FDA Recall
    Terminated ·Inverness Medical Professional Diagnostics·Product code LCX·February 12, 2010

    NOW Legionella Urinary Antigen Test. 22 test kit. For In Vitro Diagnostic Use Product Code: 852-000

    FDA Recall
    Terminated ·Inverness Medical Professional Diagnostics·Product code MJH·September 29, 2006

    BioStar OIA FLU AB, Catalog 90007. Packaged 30 devices per tray. BioStar, Louisville, CO 80027

    FDA Recall
    Terminated ·Inverness Medical BioStar Inc.·Product code GNX·July 2, 2008

    Clearview Simplify D-dimer, in vitro diagnostic for qualitative detection of D-dimer in human whole blood and plasma. Product No. 61100KVC 10 test devices containing anti D-dimer monoclonal antibody and sheep anti-mouse antibody 1 x 2.6 mL buffer containing 0.9% sodium chloride and 0.05% sodium azide 10 plastic pipettes Wampole Laboratories Inverness Medical Professional diagnostics group Manufactured by Agen Biomedical Ltd, Brisbane, QLD Australia.

    FDA Recall
    Terminated ·Inverness Medical Professional Diagnostics·Product code GHH·February 15, 2007

    Implantable Cardioverter Defibrillators (ICDs), Evera. Labeled as the following: a. Evera S DR ICD DF1 (Product No. DDBC3D1); b. Evera S VR ICD DF1 (Product No. DVBC3D1); c. Evera S VR ICD DF4 (Product No. DVBC3D4); d. Evera XT DR ICD DF1 (Product No. DDBB1D1); e. Evera XT VR ICD DF1 (Product No. DVBB1D1); f. Evera XT VR ICD DF4 (Product No. DVBB1D4); EXPANSION: g. Evera S DR ICD DF4 (Product No. DDBC3D4); h. Evera XT DR ICD DF1 Gold (Product No. DDBB1D1G); i. Evera XT DR ICD DF4 (Product No. DDBB1D4) Implantable devices that automatically detect and treat episodes of ventricular fibrillation, ventricular tachycardia, fast ventricular tachycardia, and bradyarrhythmia. Some devices can also provide resynchronization therapy, including sequential biventricular pacing (CRT-D devices).

    FDA Recall
    Terminated ·Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)·Product code LWS·December 19, 2017

    Pinnacle3 VCC P/N 4598 001 41341 REV A, Philips Medical Systems (Cleveland), Inc., Fitchburg, WI. Pinnacle3 Radiation Therapy Planning System is a computer software package intended to provide support for radiation therapy treatment planning for the treatment of benign or malignant disease processes. Pinnacle3 Radiation Therapy Planning System assists the clinician in formulating a treatment plan that maximizes the dose to the treatment volume while minimizing the dose to the surrounding normal tissues. The system is capable of operating in both the forward planning and inverse planning modes. The device is indicated for use in patients deemed to be acceptable candidates for radiation treatment in the judgment of the clinician responsible for patient care. Plans generated using this system are used in the determination of the course of a patient's radiation treatment. They are to be evaluated, modified and implemented by qualified medical personnel.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland), Inc.·November 14, 2012

    Pinnacle3 VCC P/N 4598 001 41341 REV A, Philips Medical Systems (Cleveland), Inc., Fitchburg, WI. Pinnacle3 Radiation Therapy Planning System is a computer software package intended to provide support for radiation therapy treatment planning for the treatment of benign or malignant disease processes. Pinnacle3 Radiation Therapy Planning System assists the clinician in formulating a treatment plan that maximizes the dose to the treatment volume while minimizing the dose to the surrounding normal tissues. The system is capable of operating in both the forward planning and inverse planning modes. The device is indicated for use in patients deemed to be acceptable candidates for radiation treatment in the judgment of the clinician responsible for patient care. Plans generated using this system are used in the determination of the course of a patient's radiation treatment. They are to be evaluated, modified and implemented by qualified medical personnel.

    FDA Recall
    Terminated ·Philips Medical Systems (Cleveland), Inc.·Product code IYE·October 5, 2012

    eFilm Workstation 4.0 and 4.0.1. eFilm Workstation is one of the components of a PACS (Picture Archiving and Communications System). Product Usage: eFilm Workstation is a software application that is used for viewing medical images. eFilm Workstation receives digital images and data from various sources (including but not limited to CT,MR, US, RF units, computed and direct radiographic devices, secondary capture devices, scanners, imaging gateways or imaging sources). Images are stored, communicated, processed and displayed on the local disc of a workstation and/or across computer networks at distributed locations. Tasks that users may perform when viewing images include, but are not limited to: adjustment of window width and level; image stacking; annotation and measurement of regions of interest; and inversion, rotation, and flips of images. In addition, eFilm Workstation can be integrated with an institution s existing HIS or RIS for a fully integrated electronic patient record.

    FDA Enforcement
    Class II ·Terminated·Merge Healthcare, Inc.·October 22, 2014

    eFilm Workstation 4.0 and 4.0.1. eFilm Workstation is one of the components of a PACS (Picture Archiving and Communications System). Product Usage: eFilm Workstation is a software application that is used for viewing medical images. eFilm Workstation receives digital images and data from various sources (including but not limited to CT,MR, US, RF units, computed and direct radiographic devices, secondary capture devices, scanners, imaging gateways or imaging sources). Images are stored, communicated, processed and displayed on the local disc of a workstation and/or across computer networks at distributed locations. Tasks that users may perform when viewing images include, but are not limited to: adjustment of window width and level; image stacking; annotation and measurement of regions of interest; and inversion, rotation, and flips of images. In addition, eFilm Workstation can be integrated with an institution s existing HIS or RIS for a fully integrated electronic patient record.

    FDA Recall
    Terminated ·Merge Healthcare, Inc.·Product code LLZ·August 28, 2014