BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-0915-2007 · Initiated February 5, 2007

    Recall

    Recall Number
    Z-0915-2007
    Event Number
    37775
    Firm
    General Electric Med Systems LLC
    FEI Number
    2126677
    Product Code
    MQB
    Status
    Terminated
    Root Cause
    Other
    Initiated
    February 5, 2007
    Posted
    June 9, 2007
    Terminated
    December 17, 2011
    Address
    3000 N Grandview Blvd, Waukesha, WI, 53188-1615

    Description

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

    Reason

    Unintended Gantry Movements : GE Healthcare has recently become aware of accidental, operated-initiated activation of gantry movements associated with the new, metallic Smart Box controller that may impact patient or staff safely.

    Action

    Consignees were contacted via a letter "Urgent: Safety Notice" dated 2/5/07. The letter described the safety issue, affected product, safety instructions and product correction contact information. -This is the short-term fix, GE is working on a correction that will be installed at each site as the long term correction

    Distribution

    Class II Recall - Worldwide Distribution --- USA including states of WV, WI, WA, VA, UT, TX, TN, SD, SC, PA, OR, OK,OH, NY, NV, NJ, NE, NC, MT, MO, MN, MI, ME, MD, MA, LA, KY, KS, IN, IL, ID, HI, GU, GA, FL, DE, CT, CO, CA, AZ, AL, AK and countries of UNITED KINGDOM, TURKEY, SYRIA, SWITZERLAND, SWEDEN, SPAIN, SAUDI ARABIA, RUSSIA, POLAND, NORWAY, NEW ZEALAND, THE NETHERLANDS, MOROCCO, MALAYSIA, KOREA, JORDAN, JAPAN, ITALY, ISREAL, IRELAND, INDIA, HUNGARY, GREECE, GERMANY, FRANCE, FINLAND , DENMARK, CZECH REPUBLIC, CHINA, CANADA, BELGIUM, AUSTRALIA, and ALGERIA.

    Quantity

    80