BEUDAMED
    FDA Enforcement Class II 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 · Reported July 25, 2012

    Enforcement

    Recall Number
    Z-1993-2012
    Event ID
    62527
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    GE Healthcare, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 25, 2012
    Initiation Date
    April 4, 2012
    Classification Date
    July 19, 2012
    Termination Date
    January 10, 2013
    Address
    3000 N Grandview Blvd, Waukesha, WI, 53188-1615, United States

    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.

    Code Info

    Model Numbers Optima XR200 15kw Optima XR 200 30kw Optima XR 220 15kw Optima XR 220 30kw

    Distribution

    Worldwide Distribution (USA) nationwide

    Quantity

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