BEUDAMED
    FDA Recall Terminated

    GE Healthcare Optima Mobile X-ray System. The GE Automatic Mobile X-Ray (AMX ) Series are intended to take exposures utilizing film or computed radiography ( CR )

    Recall: Z-1993-2012 · Initiated April 4, 2012

    Recall

    Recall Number
    Z-1993-2012
    Event Number
    62527
    Firm
    GE Healthcare, LLC
    FEI Number
    2126677
    Product Code
    IZL
    Status
    Terminated
    Root Cause
    Radiation Control for Health and Safety Act
    Initiated
    April 4, 2012
    Posted
    July 19, 2012
    Terminated
    January 10, 2013
    Address
    3000 N Grandview Blvd, Waukesha, WI, 53188-1615

    Description

    GE Healthcare Optima Mobile X-ray System. The GE Automatic Mobile X-Ray (AMX ) Series are intended to take exposures utilizing film or computed radiography ( CR )

    Reason

    GE Healthcare has become aware of a software issue on the interface of the mobile radiographic product, Optima XR200amx, ond Optima XR220amx related to Visual indication as mandated by the US Code of Federal Regulations (21CFR) and IEC 60601-1-3.

    Action

    GE Healthcare will, without charge, remedy the defect or bring the product into compliance with each applicable Federal and IEC standard in accordance with a plan to be approved by the Secretary of Health and Human Services, the details of which will be included in a subsequent communication to the user or through a GE Healthcare field engineer site visit. A GE Healthcare Service Representative will update the firmware on the system to address the issue. Your proposed corrective action plan (CAP) (Field Modification Instructions 10865) describes the rework plan that GEHC Engineers will make to the imaging system to return it to compliance with the applicable performance standard. It appears to adequately address the problem and is hereby approved.

    Distribution

    Worldwide Distribution (USA) nationwide

    Quantity

    254 units have been shipped to/installed in the U.S.