BEUDAMED
    FDA Recall Terminated

    GE Healthcare Optima XR 200amx with digital upgrade Mobile general purpose radiographic imaging of the human head and body.

    Recall: Z-0197-2013 · Initiated September 20, 2012

    Recall

    Recall Number
    Z-0197-2013
    Event Number
    63597
    Firm
    GE Healthcare, LLC
    FEI Number
    2126677
    Product Code
    OXO
    Status
    Terminated
    Root Cause
    Radiation Control for Health and Safety Act
    Initiated
    September 20, 2012
    Posted
    November 16, 2012
    Terminated
    December 5, 2013
    Address
    3000 N Grandview Blvd, Waukesha, WI, 53188-1615

    Description

    GE Healthcare Optima XR 200amx with digital upgrade Mobile general purpose radiographic imaging of the human head and body.

    Reason

    It was discovered GE Healthcare has become aware of a firmware issue on the mobile radiographic product, Brivo XR285amx, Optima XR200amx, Optima XR22Oamx and Optima XR200amx with Digital Upgrade, related to Technique Accuracy as mandated by the US Code of Federal Regulations (21CFR) and IEC 60601-2-54.

    Action

    GE Healthcare will remedy the defect or bring the product into compliance with each applicable Federal and IEC standard. A Service Representative will update the firmware on the system to address the issue. Field Modification Instructions (FMI) 10870, 10872, and 10873 are describing the rework plan the GEHC Engineers will make to the imaging systems compliant with the applicable performance standard. Further questions please call (262) 513-4122.

    Distribution

    Nationwide Distribution

    Quantity

    364 total units installed in US