BEUDAMED
    FDA Recall Terminated

    Emission Computed Tomography System. Including Model numbers: 2200967, ASM001080, ASM001083, ASM001092, ASM001099, ASM000085, 10036800109, and Varicam.

    Recall: Z-0012-05 · Initiated September 3, 2004

    Recall

    Recall Number
    Z-0012-05
    Event Number
    29988
    Firm
    General Electric Med Systems LLC
    FEI Number
    2126677
    Product Code
    KPS
    Status
    Terminated
    Root Cause
    Other
    Initiated
    September 3, 2004
    Posted
    October 7, 2004
    Terminated
    July 24, 2006
    Address
    3000 N Grandview Blvd, Waukesha, WI, 53188-1615

    Description

    Emission Computed Tomography System. Including Model numbers: 2200967, ASM001080, ASM001083, ASM001092, ASM001099, ASM000085, 10036800109, and Varicam.

    Reason

    GE Healthcare received reports of intermittent low ejection fraction (EF) results for MUGA (multi-gated acquisitions) studies on Millennium VG systems. This issue can occasionally lead to distortions in the volume curve in some MUGA studies, and result in calculated EF values lower (never higher) than actual values. A low EF value could lead to a physician decision to stop needed treatment.

    Action

    A letter dated August 5, 2004 was released to customers describing the issue and recommending that users pay special attention to any volume curve which appears to be abnormal or any EF values that appear to be lower than expected, and not to rely soley on this value for diagnosis purposes until they recieve the SW patch. A SW patch will be distributed shortly to all affected systems.

    Distribution

    Nationwide throughout the United States and worldwide.

    Quantity

    853 units