BEUDAMED
    FDA Recall Terminated

    Optima XR200amx. Mobile general purpose radiographic imaging of the human head and body.

    Recall: Z-2256-2012 · Initiated July 10, 2012

    Recall

    Recall Number
    Z-2256-2012
    Event Number
    62946
    Firm
    GE Healthcare, LLC
    FEI Number
    2126677
    Product Code
    IZL
    Status
    Terminated
    Root Cause
    Radiation Control for Health and Safety Act
    Initiated
    July 10, 2012
    Posted
    September 13, 2012
    Terminated
    January 10, 2013
    Address
    3000 N Grandview Blvd, Waukesha, WI, 53188-1615

    Description

    Optima XR200amx. Mobile general purpose radiographic imaging of the human head and body.

    Reason

    Software issue: a violation of 21 CFR 1020.31(a). After an image is taken, when the user selects and clears an additionally displayed screen the system inhibit is also cleared, allowing the user to take an exposure without the technique factors being displayed.

    Action

    The firm will issue Important Electronic Product Radiation Warning letters that identify the affected product along with a description of the defect and related hazards. Users are instructed to ensure that the acquisition mode is always selected prior to attempting an exposure to confirm the techniques selected. The firm will remedy the issue or bring the device into compliance free of charge. A GE Healthcare Service Representative will update the software on the system to address the issue. Field Modification Instructions (FMI) 10865(2) describes the rework plan the 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. Users are to contact 800-437-1171 in the US, if they have any questions or concerns.

    Distribution

    Worldwide Distribution -- USA (nationwide) Distribution

    Quantity

    254 total in the US