BEUDAMED
    FDA Recall Terminated

    GE Healthcare Innova 2100 IQ Digital Fluoroscopic Imaging System (Versatile cardiac and vascular).

    Recall: Z-1043-2007 · Initiated March 26, 2007

    Recall

    Recall Number
    Z-1043-2007
    Event Number
    37733
    Firm
    General Electric Med Systems LLC
    FEI Number
    2126677
    Product Code
    MQB
    Status
    Terminated
    Root Cause
    Other
    Initiated
    March 26, 2007
    Posted
    July 10, 2007
    Terminated
    October 21, 2008
    Address
    3000 N Grandview Blvd, Waukesha, WI, 53188-1615

    Description

    GE Healthcare Innova 2100 IQ Digital Fluoroscopic Imaging System (Versatile cardiac and vascular).

    Reason

    Caution on the non-detection of small invasive objects/devices, which project out from the skin surfaces (e.g. biopsy or other needles) while using the Innova Sense software option designed for patient contouring. Usage of Innova Sense patient contouring for such devices could potentially lead to patient injury.

    Action

    A "GE Healthcare Urgent: Safety Notice" dated January 24, 2007 was sent to consignees describing the product, problem, safety instructions, product correction and contact information.

    Distribution

    Worldwide, including USA, Guam, Canada, Australia, China, India, Japan, Korea, Malaysia, New Zealand, Algeria, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Italy, Jordan, Morocco, Norway, Poland, Russia, Saudi Arabia, Spain, Sweden, Switzerland, Syria, Turkey, and United Kingdom.

    Quantity

    205