BEUDAMED
    FDA Recall Terminated

    GE Optima CT520 and Optima CT540 Computed Tomography (CT) systems. Intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes.

    Recall: Z-0840-2014 · Initiated October 9, 2013

    Recall

    Recall Number
    Z-0840-2014
    Event Number
    66917
    Firm
    GE Healthcare, LLC
    FEI Number
    2126677
    Product Code
    JAK
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    October 9, 2013
    Posted
    January 27, 2014
    Terminated
    June 19, 2014
    Address
    3000 N Grandview Blvd, Waukesha, WI, 53188-1615

    Description

    GE Optima CT520 and Optima CT540 Computed Tomography (CT) systems. Intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes.

    Reason

    There is an issue with the Manual Film Composer feature on some CT products. There is an opportunity, while following a specific workflow, to create a film image with one patient's images and another patient's name in the footer. This is also an issue when within Manual Film Composer, if a color image is selected for printing, another patient's black and white image appears in the preview screen

    Action

    Consignees were sent on 10/9/2013 a GE Healthcare "Urgent Medical Device Correction" letter dated October 9, 2013. The letter was addressed to Hospital Administrators / Risk Managers, Radiology Directors and Radiologists. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Information (Contact your local GE Healthcare Service Representative or the GE Healthcare Call Center : US or Canada : 800-437-1171 and Other countries: 262-896-2890).

    Distribution

    Worldwide Distribution-USA (nationwide) including the states of AL, CO, FL, IN, KS, KY, MN, NC, OH, TX, and VA, and the countries of ALGERIA, AUSTRALIA, BELGIUM, BULGARIA, CANADA, CHINA, ABIDJAN COTEDIVOIRE EGYPT, FRANCE, GERMANY, GREAT BRITAIN, INDIA, IRAQ, ITALY, JAPAN, KENYA, LATVIA, LEBANON, MALAYSIA, MARTINIQUE,MOROCCO, NEW ZEALAND, NORWAY, PAKISTAN, POLAND, PORTUGAL ROMANIA, RUSSIAN FEDERATION, SAUDI ARABIA, SOUTH AFRICA, SPAIN, SWITZERLAND, THAILAND, TUNISIA, TURKEY, UNITED ARAB EMIRATES, and VIETNAM.

    Quantity

    272 (29 US; 243 OUS)