BEUDAMED
    FDA Recall Terminated

    Definium 5000 X-ray System, model number 5220493 and 5220393-2

    Recall: Z-1118-2009 · Initiated March 24, 2009

    Recall

    Recall Number
    Z-1118-2009
    Event Number
    51490
    Firm
    GE Healthcare, LLC
    FEI Number
    2126677
    Product Code
    KPR
    Status
    Terminated
    Root Cause
    Radiation Control for Health and Safety Act
    Initiated
    March 24, 2009
    Posted
    September 25, 2009
    Terminated
    May 16, 2012
    Address
    3000 N Grandview Blvd, Waukesha, WI, 53188-1615

    Description

    Definium 5000 X-ray System, model number 5220493 and 5220393-2

    Reason

    A defect in the AEC board in the system's control causes failure to terminate additional exposures at the exposure time selected for the initial exposure.

    Action

    A notification was sent to all affected customer sites alerting them to this issue, with instructions for safe use of the affected systems.

    Distribution

    Nationwide Distribution

    Quantity

    85