BEUDAMED
    FDA Recall Terminated

    GE Healthcare IDI Mammo Workstation

    Recall: Z-0477-2011 · Initiated August 28, 2009

    Recall

    Recall Number
    Z-0477-2011
    Event Number
    57077
    Firm
    GE Healthcare, LLC
    FEI Number
    2126677
    Product Code
    LLZ
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    August 28, 2009
    Posted
    November 26, 2010
    Terminated
    June 5, 2012
    Address
    3000 N Grandview Blvd, Waukesha, WI, 53188-1615

    Description

    GE Healthcare IDI Mammo Workstation

    Reason

    The measurement values provided by the GE Workstation may be incorrect when applied to magnification images acquired on non-GE digital mammography systems. If not noticed by the caregiver, this could lead to an overestimate of the size of the breast lesion that may impact patient treatment and safety. The measurement values for GE images are not affected.

    Action

    GE Healthcare issued "Urgent Medical Device Correction" letters dated August 28, 2009 or August 31, 2009 to either Seno Advantage Customers (Hospital Administrators/Risk Mangers, Radiology Department Managers), and Image Diagnostic Customers (Hospital Administrators/Risk Managers, Radiology Department Managers). The letters described the Safety Issue, Affected Product Details, safety Instructions, Product correction and Contact Information. GE will linstall new software with the release of Field Modification Instruction 12129. Customers can contact GE Healthcare about this issue at 800-437-1171.

    Distribution

    Worldwide Distribution: USA in the states of AL, AK, AZ, AR, CA, CO, CT, FL, GA, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI,MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, WV, WI, and WY, and to the countries of UNITED KINGDOM, TURKEY, TAIWAN, SWITZERLAND, SPAIN, SOUTH, KOREA, SAUDI ARABIA , PORTUGAL, NEW ZEALAND, NETHERLANDS, KUWAIT, JAPAN, ITALY, GERMANY, FRANCE , CHINA, CANADA, BRAZIL, BELGIUM, AUSTRIA, AUSTRALIA, VENEZUELA, UNITED ARAB EMIRATES, THAILAND, SWEEDEN, SOUTH AFRICA, SLOVENIA, SINGAPORE, RUSSIA, PHILLIPNES, NORWAY, POLAND, MOROCCO, MEXICO, MARTINIQUE, MALAYSIA, LUXEMBOURG, LEBANON, JORDAN, JAMAICA, ISRAEL, IRELAND, INDIA, ICELAND, HUNGARY, HONG KONG, HONDURAS, GUADOPUO, GREECE, GEORGIA, FINLAND, EGYPT, DOMINICAN REPUBLIC, DENMARK, CZECH REPUBLIC, CROATIA, COLOMBIA, BULGARIA, BOTSWANA, and ALGERIA.

    Quantity

    158