BEUDAMED
    FDA Recall Terminated

    GE Healthcare Innova 4100/4100 IQ. Digital Fluoroscopic Imaging System (Vascular Angiography System)

    Recall: Z-0869-2007 · Initiated March 26, 2007

    Recall

    Recall Number
    Z-0869-2007
    Event Number
    37723
    Firm
    General Electric Med Systems LLC
    FEI Number
    2126677
    Product Code
    MQB
    Status
    Terminated
    Root Cause
    Other
    Initiated
    March 26, 2007
    Posted
    June 5, 2007
    Terminated
    October 21, 2008
    Address
    3000 N Grandview Blvd, Waukesha, WI, 53188-1615

    Description

    GE Healthcare Innova 4100/4100 IQ. Digital Fluoroscopic Imaging System (Vascular Angiography System)

    Reason

    Measurement errors during the computation of vessel diameters while using the Stenosis Analysis software (also known as Quantitative Coronary Analysis function-QCA) using the auto-calibration function on Innova Digital (located in control room) or in-room InnovaCentral/Touch-Screen

    Action

    A letter dated Jan. 18, 2007, was sent to consignees describing the problem, product ,safety instructions and contact information. Software upgrades were promised for correction.

    Distribution

    Worldwide Distribution: USA states including-AZ,CA,CO,DE,FL,GA,IL,IN, MD,MN,MO,NJ,NV,NY,OH,OK,OR,PA,SC,SD,TX, UT, VA,WA,WI, and countries of Canada, Belgium, China, Czech Republic, Finland, France, Germany, Hungary, India, Isreal, Italy, Japan, Korea, New Zealand, Norway, Russia, Spain, and United Kingdom.

    Quantity

    70