BEUDAMED
    FDA Enforcement Class II Terminated

    Optima XR220amx Mobile general purpose radiographic imaging of the human head and body.

    Recall: Z-2255-2012 · Reported September 19, 2012

    Enforcement

    Recall Number
    Z-2255-2012
    Event ID
    62946
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    GE Healthcare, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 19, 2012
    Initiation Date
    July 10, 2012
    Classification Date
    September 13, 2012
    Termination Date
    January 10, 2013
    Address
    3000 N Grandview Blvd, N/A, Waukesha, WI, 53188-1615, United States

    Description

    Optima XR220amx 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.

    Code Info

    Part Numbers: 5555000-3, 5555000-4, 5555000-5, 5555000-6.

    Distribution

    Worldwide Distribution -- USA (nationwide) Distribution

    Quantity

    254 total in the US