BEUDAMED
    FDA Recall Terminated

    GE SENOGRAPHE DS FULL FIELD DIGITAL ESSENTIAL MAMMOGRAPHY SYSTEM. The Senographe DS system generates digital mammographic images, which can be used for screening and diagnosis of breast cancer. The Senographe DS is intended to be used in the same clinical applications as traditional mammographic film/screen systems.

    Recall: Z-0115-2012 · Initiated September 22, 2011

    Recall

    Recall Number
    Z-0115-2012
    Event Number
    59326
    Firm
    GE Healthcare, LLC
    FEI Number
    2126677
    Product Code
    MUE
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    September 22, 2011
    Posted
    October 26, 2011
    Terminated
    October 16, 2012
    Address
    3000 N Grandview Blvd, Waukesha, WI, 53188-1615

    Description

    GE SENOGRAPHE DS FULL FIELD DIGITAL ESSENTIAL MAMMOGRAPHY SYSTEM. The Senographe DS system generates digital mammographic images, which can be used for screening and diagnosis of breast cancer. The Senographe DS is intended to be used in the same clinical applications as traditional mammographic film/screen systems.

    Reason

    GE Healthcare has become aware of inaccurate measurement on GE magnified images provided by Senographe DS and Essential 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 September 21, 2011 to all affected customers. The letter describes the products, problem, and actions to be taken by the customers. The letter provides safety instructions and advises customers to complete and return a Customer Reply Form via fax to +33(0)1 30 70 39 30. A GE Healthcare service representative will contact customers if the updated software version is required. Contact the Call Center at 800-437-1171.

    Distribution

    Worldwide Distribution-USA (nationwide) including Puerto Rico and Washington, D.C. and the countries of ALGERIA, AUSTRALIA, AUSTRIA, BELGIUM BOTSWANA, BRAZIL, BULGARIA, CANADA, CHILE, CHINA, COLOMBIA, CROATIA, CZECH REPUBLIC, DENMARK, EGYPT, FINLAND, FRANCE, GEORGIA,GERMANY, GREECE, GUADELOUPE, GUYANA, HONDURAS, HONG KONG, HUNGARY, INDIA, IRAQ, IRELAND, ISRAEL, ITALY, JAPAN, JORDAN, KUWAIT, LATVIA, LEBANON, LIBYAN ARAB JAMAHIRIYA, LITHUANIA, LUXEMBOURG, MALAYSIA, MALTA, MARTINIQUE, MEXICO, MOROCCO, NETHERLANDS, NEW ZEALAND, NIGERIA, NORWAY, PAKISTAN, PHILIPPINES, POLAND, PORTUGAL, REPUBLIC OF KOREA, RUSSIAN FEDERATION SAINT PIERRE AND MIQUELON, SAUDI ARABIA, SINGAPORE, SLOVAKIA, SLOVENIA, SOUTH AFRICA, SPAIN, SUDAN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, THE FORMER YUGOSLAV REPUBLIC OF MECEDONIA, TUNISIA, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM, AND VENEZUELA.

    Quantity

    1344