BEUDAMED
    FDA Recall Terminated

    Definium AMX 700 Digital mobile x-ray system, GE Healthcare 3000 North Grandview Waukesha, WI

    Recall: Z-0821-2007 · Initiated December 21, 2006

    Recall

    Recall Number
    Z-0821-2007
    Event Number
    37848
    Firm
    GE Medical Systems LLC
    FEI Number
    2183553
    Product Code
    IZL
    Status
    Terminated
    Root Cause
    Other
    Initiated
    December 21, 2006
    Posted
    May 22, 2007
    Terminated
    February 24, 2008
    Address
    3200 N Grandview Blvd, Waukesha, WI, 53188-1693

    Description

    Definium AMX 700 Digital mobile x-ray system, GE Healthcare 3000 North Grandview Waukesha, WI

    Reason

    When using the Tech Switch on exposures >750ms, >100 kVp and > 100 mAs the exposure terminates prematurely.

    Action

    Visit to each consignee beginning December 21, 2006.

    Distribution

    Product was distributed in the following states: MS, NE, NJ, and, TX

    Quantity

    6 units