BEUDAMED
    FDA Enforcement Class II Terminated

    GE Healthcare Automatic Mobile X-Ray (AMX) Series: Optima XR220 amx

    Recall: Z-1407-2015 · Reported May 6, 2015

    Enforcement

    Recall Number
    Z-1407-2015
    Event ID
    70924
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    GE Healthcare
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 6, 2015
    Initiation Date
    December 19, 2014
    Classification Date
    April 27, 2015
    Termination Date
    April 29, 2015
    Address
    3000 N Grandview Blvd, Waukesha, WI, 53188-1615, United States

    Description

    GE Healthcare Automatic Mobile X-Ray (AMX) Series: Optima XR220 amx

    Reason

    An issue was identified with the mAs accuracy check performed on the system that could result in inaccuracies in the 10% to 20% range for exposure times longer than 15 msec.

    Code Info

    OptimaXR220amx PN 5555000-5, PN5555000-6

    Distribution

    US Distribution to the states of: AZ, FL, GA, MO and WI.

    Quantity

    6 units in US