BEUDAMED
    FDA Recall Terminated

    Optima MR450w, Discovery MR450, Discovery MR750, Signa HDx, Signa HDxt, Signa HDi, Signa Vibrant, and GE 1.5T Signa HDe MR System. The GE Signa HDx MR system is a whole body magnetic resonance scanner.

    Recall: Z-0935-2013 · Initiated May 10, 2011

    Recall

    Recall Number
    Z-0935-2013
    Event Number
    64291
    Firm
    GE Healthcare, LLC
    FEI Number
    2126677
    Product Code
    LNH
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    May 10, 2011
    Posted
    March 11, 2013
    Terminated
    June 30, 2016
    Address
    3000 N Grandview Blvd, Waukesha, WI, 53188-1615

    Description

    Optima MR450w, Discovery MR450, Discovery MR750, Signa HDx, Signa HDxt, Signa HDi, Signa Vibrant, and GE 1.5T Signa HDe MR System. The GE Signa HDx MR system is a whole body magnetic resonance scanner.

    Reason

    An error on the SR Viewer Reporting Tool in which edits can be made on a report and can be saved into incorrect reports.

    Action

    GE Healthcare sent an Urgent Field Safety Notice dated May 5, 2011, to all affected customers. The letter described the Safety Issue, Affected Product Details, Safety Instructions, Product Correction and Contact Information. Customers were instructed to open only one patient report at a time when editing a report in SR Viewer. US Customers did not receive a customer letter, however all US systems have been updated. For questions customers were instructed to contact their local Sales/Service Representative. For questions regarding this recall call 262-513-4122.

    Distribution

    Worldwide Distribution - USA (All States in continental USA including PR except RI.). Internationall to: ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, AZERBAIJAN, BRAZIL, BELARUS, BELGIUM, BULGARIA, BOSNIA & HERZEGOVINA, CANADA, CHILE, CHINA, COLOMBIA, CROATIA, CZECH REPUBLIC, DENMARK, EGYPT, ESTONIA, FINLAND, FRANCE, FRENCH POLYNESIA, GEORGIA, GERMANY, GREECE, GUADELOUPE, HONDURAS, HUNGARY, INDIA, INDONESIA, IRAN, ISLAMIC REPUBLIC OF IRAN, IRAQ, ITALY, IRELAND, ISRAEL, JAPAN, JORDAN, KENYA, KOREA, KUWAIT, KAZAKHSTAN, LATVIA, LEBANON, LIBYA, LITHUANIA, LUXEMBOURG, MALAYSIA, MEXICO, MACEDONIA, MARTINIQUE, MOROCCO, NETHERLANDS, NORWAY, PAKISTAN, PERU, PHILIPPINES, REUNION, NEW ZEALAND, OMAN, POLAND, PORTUGAL, ROMANIA, RUSSIAN FEDERATION, SAUDI ARABIA, SERBIA, SOUTH AFRICA, SPAIN, SUDAN, SWEDEN, SINGAPORE , SLOVAKIA, SOUTH KOREA, SWITZERLAND, SYRIA, TAIWAN, THAILAND, TURKEY, TUNISIA, UNITED ARAB EMIRATES, UNITED KINGDOM, UZBEKISTAN, VENEZUELA, URUGUAY, VIET NAAM, and YUGOSLAVIA.

    Quantity

    4026 (1672 US; 2354 OUS)