BEUDAMED
    FDA Recall Terminated

    GE Signa Ovation 0.35 T MR System. The Signa Ovation System is an open, whole body scanner designed to support improved higher resolution imaging and shorter scan times.

    Recall: Z-1556-2009 · Initiated April 16, 2009

    Recall

    Recall Number
    Z-1556-2009
    Event Number
    52015
    Firm
    GE Medical Systems, LLC
    FEI Number
    2126677
    Product Code
    LNH
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    April 16, 2009
    Posted
    June 30, 2009
    Terminated
    April 23, 2013
    Address
    3000 N Grandview Blvd, Waukesha, WI, 53188-1615

    Description

    GE Signa Ovation 0.35 T MR System. The Signa Ovation System is an open, whole body scanner designed to support improved higher resolution imaging and shorter scan times.

    Reason

    GE Healthcare has identified a potential safety issue with the Signa OpenSpeed and Signa Ovation MR Scanner tables that may impact patient safety. The table may begin lowering on its own while a patient is on the table. If this occurs while the table is in the magnet bore, the table may tilt and could result in patient injury. The patient's head or feet depending on patient orientation, may hit

    Action

    GE Healthcare issued an "Urgent Medical Device Correction" letter dated April 16, 2009 addressed to Hospital Administrators, Mangers of Radiology/Cardiology and Radiologists/Cardiologists. The letter describes the Safety Issue, Affected Product Details, Safety Instructions, Product Correction and Contact Information. A GE Healthcare Field Engineer will schedule a field visit to correct the device. Further questions or concerns may be addressed to GE Healthcare at 1-262-521-6681.

    Distribution

    Worldwide Distribution -- US including PR and states of AL, AZ, AR, CA, CO,CT, DE, FL, GA, ID, IL, IN, IA, KS, KY, LA, MD, MA, MI, MN, MN, MS, MO,MT, NV, NH, NE, NJ, NY, NC, OH, OK,OR, PA, SC, SD, TN, TX, VA, WA, WV, WI and countries of BRAZIL CHINA, DENMARK, EGYPT, ENGLAND, GERMANY, GUATEMALA, HUNGARY, ITALY, IVORY COAST, JAPAN, KOREA, KUWAIT, OMAN, MEXICO, OMAN, PHILIPPINES, RUSSIAN FEDERATION, SPAIN, SWITZERLAND, TURKEY, UNITED ARAB EMIRATES and VENEZUELA.

    Quantity

    203