BEUDAMED
    FDA Recall Terminated

    GE Innova 3100 / 3100 IQ, Cardiovascular Imaging System, GE Healthcare, Waukesha, WI 53188 (The system consists of an a monoplane positioner, a vascular or cardiac table, an X-ray system and a digital detector) Indicated for use in diagnostic and interventional angiographic procedures of human anatomy. Intended to replace image intensifier fluoroscopic systems in all diagnostic or interventional procedures. Not intended for mammography applications.

    Recall: Z-1092-2009 · Initiated March 6, 2008

    Recall

    Recall Number
    Z-1092-2009
    Event Number
    51159
    Firm
    GE Medical Systems, LLC
    FEI Number
    2126677
    Product Code
    MQB
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    March 6, 2008
    Posted
    March 12, 2009
    Terminated
    September 4, 2014
    Address
    3000 N Grandview Blvd, Waukesha, WI, 53188-1615

    Description

    GE Innova 3100 / 3100 IQ, Cardiovascular Imaging System, GE Healthcare, Waukesha, WI 53188 (The system consists of an a monoplane positioner, a vascular or cardiac table, an X-ray system and a digital detector) Indicated for use in diagnostic and interventional angiographic procedures of human anatomy. Intended to replace image intensifier fluoroscopic systems in all diagnostic or interventional procedures. Not intended for mammography applications.

    Reason

    GE Healthcare reported an issue with the Exposure Switch Redundancy system with Innova Systems 3100 & 4100, in which this error stays on, even after the pedal is released, inhibiting further x-rays, and a system reset is required to recover.

    Action

    On site visits were performed from 3/6/08 - 12/19/08 to update software on all 5 units.

    Distribution

    Worldwide Distribution -- USA including states of MD, TX, and VA and country of China.

    Quantity

    4