BEUDAMED
    FDA Enforcement Class II Terminated

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

    Recall: Z-0199-2013 · Reported November 28, 2012

    Enforcement

    Recall Number
    Z-0199-2013
    Event ID
    63597
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    GE Healthcare, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 28, 2012
    Initiation Date
    September 20, 2012
    Classification Date
    November 16, 2012
    Termination Date
    December 5, 2013
    Address
    3000 N Grandview Blvd, N/A, Waukesha, WI, 53188-1615, United States

    Description

    GE Healthcare Optima 200amx 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.

    Code Info

    part numbers: 5555000-3, 5555000-4

    Distribution

    Nationwide Distribution

    Quantity

    364 total units installed in US