BEUDAMED
    FDA Recall Terminated

    Sytec 6000, Sytec 8000, and Lemage/ProSeed/ProSpeed families. The CT/e and HiSpeed X/i families CT Scanner Systems are indicated for head and whole body X-ray Computed Tomography applications.

    Recall: Z-2225-2009 · Initiated December 1, 2008

    Recall

    Recall Number
    Z-2225-2009
    Event Number
    50528
    Firm
    GE Medical Systems, LLC
    FEI Number
    2126677
    Product Code
    JAK
    Status
    Terminated
    Root Cause
    Radiation Control for Health and Safety Act
    Initiated
    December 1, 2008
    Posted
    September 18, 2009
    Terminated
    January 27, 2016
    Address
    3000 N Grandview Blvd, Waukesha, WI, 53188-1615

    Description

    Sytec 6000, Sytec 8000, and Lemage/ProSeed/ProSpeed families. The CT/e and HiSpeed X/i families CT Scanner Systems are indicated for head and whole body X-ray Computed Tomography applications.

    Reason

    During internal testing, GE Healthcare has recently determined that the collimator used on our CT/e and HiSpeed X/i families of Computed Tomography systems does not comply with the specific requirements in United States Title 21 of the Code of Federal Regulations, and IEC 60601-1-3, related to leakage radiation from the diagnostic source assembly, which includes the collimator. The excess leak

    Action

    GE Healthcare issued an "Important - Electronic Product Radiation Warning" to affected customers. GE Healthcare field service representative will perform a field corrective action on all affected units. All potential users of the device should be made aware of the notification and the information contained. For further information, contact GE Healthcare at 1-800-437-1171 (US) or by contacting your local GE Healthcare service manager.

    Distribution

    Worldwide Distribution -- UNITED STATES (AL, AZ, AR, CA, CT, DC, FL, GA, IL, IN, KS, KY, LA, MD, MA, MI, LMN, MS, MO, NE, NJ, NM, NY, NC, OH, OK, PA, PR,SC, SD, TN, TX, VA, WA, WV and WI), ALGERIA, ANTIGUA, ARGENTINA, AUSTRALIA, AUSTRIA, AZERBAIJAN, BELGIUM, BENIN, BOLIVIA, BOSNIA & HERZEGOVINIA, BRAZIL BULGARIA, BYELORUSSIAN, CAMERON, CANADA, CHILE, CHINA, COLOMBIA, CONGO, COSTA RICA, CROATIA, CYPRUS, CZECH REPUBLIC, DENMARK , DOMINICAN REPUBLIC, ECUADOR, EGYPT, EL SALVADOR, ESTONIA, FINLAND, FRANCE, GEORGIA, GERMANY, GREECE, GUADELOUPE, GUATEMALA, GUYANA, HONDURAS, HONG KONG, HUNGARY, ICELAND, INDIA, INDONESIA, IRAN, IRELAND, ISRAEL, ITALY, IVORY COST, JAPAN, JORDAN, KAZAKHSTAN, KOREA, KUWAIT, LATVIA, LEBANON, LIBYAN ARAB JAMAHIRIYA, LITHUANIA, , MACEDONIA, MALAYSIA, MALTA, MARTINIQUE, MAURITANIA, MAURITIUS, MEXICO, MOROCCO, NETHERLANDS, NEW ZEALAND, NICARAGUA, NIGER, NIGERIA, NORWAY, OMAN, PAKISTAN, PANAMA, PARAGUAY, PERU, PHILIPPINES, POLAND, PORTUGAL QATAR, ROMANIA, RUSSIAN F=FEDERATION, SAUDI ARABIA, SINGAPORE, SLOVAK IA, SOUTH AFRICA, SPAIN, SUDAN, SWEDEN, SWITZERLAND , SYRIA ARAB REPUBLIC, TAIWAN, THAILAND, TRINIDAD & TOBAGO TUNISIA, TURKEY,, UGANDA, UKRAINE, UNITED KINGDOM, URUGUAY, VENEZUELA, VIETNAM, YEMEN and YUGOSLAVIA.

    Quantity

    643 units ( 136 US; 507 OUS)