BEUDAMED
    FDA Recall Terminated

    GE Healthcare DISCOVERY MODEL NM/CT 670 NM/CT system

    Recall: Z-2158-2011 · Initiated January 26, 2011

    Recall

    Recall Number
    Z-2158-2011
    Event Number
    58419
    Firm
    GE Healthcare, LLC
    FEI Number
    2126677
    Product Code
    IWE
    Status
    Terminated
    Root Cause
    Radiation Control for Health and Safety Act
    Initiated
    January 26, 2011
    Posted
    July 21, 2011
    Terminated
    August 31, 2012
    Address
    3000 N Grandview Blvd, Waukesha, WI, 53188-1615

    Description

    GE Healthcare DISCOVERY MODEL NM/CT 670 NM/CT system

    Reason

    GE Healthcare has become aware of a missing laser aperture warning label (i.e. Laser Aperture - Do Not Stare Into Beam) affecting certain Discovery Systems.

    Action

    GE Healthcare will bring affected systems into compliance. A GE Healthcare Service Representative will provide a product label correction to address this issue. This will be carried out via a Field Modification Instruction (FMVI 408311 planned to be released in June 2011 with an estimated completion date of August 2011. For questions call 262-513-4122.

    Distribution

    Nationwide Distribution

    Quantity

    4