BEUDAMED
    FDA Recall Terminated

    GE SENOGRAPHE 2000D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM ( SENO 2000D). The Senographe 2000D system generates digital mammographic images that can be used for screening and in the diagnosis of breast cancer. The Senographe 2000D is intended to be used in the same clinical applications as traditional mammographic film/screen systems.

    Recall: Z-1063-2012 · Initiated October 17, 2011

    Recall

    Recall Number
    Z-1063-2012
    Event Number
    60058
    Firm
    GE Healthcare, LLC
    FEI Number
    2126677
    Product Code
    MUE
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    October 17, 2011
    Posted
    February 20, 2012
    Terminated
    March 12, 2014
    Address
    3000 N Grandview Blvd, Waukesha, WI, 53188-1615

    Description

    GE SENOGRAPHE 2000D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM ( SENO 2000D). The Senographe 2000D system generates digital mammographic images that can be used for screening and in the diagnosis of breast cancer. The Senographe 2000D is intended to be used in the same clinical applications as traditional mammographic film/screen systems.

    Reason

    GE Healthcare has become aware of inaccurate measurements on GE magnified images provided by Senographe 2000D Mammography systems when reviewed on IHE compliant workstations. This issue may impact patient safety.

    Action

    GE Healthcare sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated October 17, 2011 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers. Contact the Call Center at 800-437-1171 for questions regarding this notice.

    Distribution

    Worldwide Distribution-USA (nationwide) including the states of AL, AZ, AR, CA,CT, DC,FL, GA, HI, ID, IL, IN, 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, VA, WV,and WI and countries of VENEZUELA, UNITED KINGDOM, UNITED ARAB EMIRATES, TURKEY, THAILAND, TAIWAN, SWITZERLAND, SPAIN, SINGAPORE, SAUDI ARABIA, RUSSIA, QATAR, PORTUGAL, POLAND, NETHERLANDS, MOROCCO, MEXICO, MALAYSIA, LEBANON, KUWAIT, KOREA, JAPAN, JAM,AICA, ITALY, IRELAND, HUNGARY, HONG KONG, HONDURAS, GREECE, GERMANY, GEORGIA, FRANCE, EGYPT, DOMINICAN REPUBLIC, COLUMBIA, CHINA, CHILE, CANADA, BRAZIL, BELGIUM, AUSTRIA, AUSTRALIA, and ARGENTINA.

    Quantity

    1060