BEUDAMED
    FDA Recall Terminated

    GE LightSpeed CT750 HD The GE LightSpeed CT750 HD Computed Tomography X-ray system is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes, including Axial, Cine, Helical (Volumetric), Cardiac, Spectral, and Gated acquisitions for all ages.

    Recall: Z-1940-2013 · Initiated April 5, 2011

    Recall

    Recall Number
    Z-1940-2013
    Event Number
    65333
    Firm
    GE Healthcare, LLC
    FEI Number
    2126677
    Product Code
    JAK
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    April 5, 2011
    Posted
    August 9, 2013
    Terminated
    August 11, 2014
    Address
    3000 N Grandview Blvd, Waukesha, WI, 53188-1615

    Description

    GE LightSpeed CT750 HD The GE LightSpeed CT750 HD Computed Tomography X-ray system is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes, including Axial, Cine, Helical (Volumetric), Cardiac, Spectral, and Gated acquisitions for all ages.

    Reason

    GE Healthcare conducted a recall involving 2 events affecting the GE LightSpeed CT750 HD. Event 1 - There was a report regarding CT number variance in time line at posterior fossa region of head perfusion. When beam hardening and helical artifacts in this region are reconstructed into the perfusion map, these artifacts will give subtle differences in the CT numbers. Event 2 - The software does no

    Action

    GE Healthcare's recall strategy was to update CT750HD CT Systems with software 10MW25.6 on all systems that were distributed. Updates started on 4/5/2011. At this time, deployment of this recall is considered complete. The recall was completed 2/2/2012. Should you have any questions or require additional information, please contact Regulatory Affairs Leader by telephone at 262-548-2198 or email [email protected].

    Distribution

    Worldwide distribution: US (nationwide) including states of: AL, AZ, CA, CT, FL, GA, HI, IL, IN, IA, KY,ME, MD,MA, MI,MN, MS, NV, NH, NJ, NY, NC, PA, TN, TX, VA, WA,WV, and WI; and countries of: AUSTRALIA, BELGIUM, BRAZIL, CANDA, CHINA, DENMARK, FINLAND, FRANCE, GERMANY, GREECE, HONG KONG, INDIA, INDONESIA, IRELAND, ISRAEL, ITALY, JAPAN,JORDAN, REPUBLIC OF KOREA, KUWAIT, LATVIA, NEW ZEALAND, POLAND, RUSSIAN FEDERATION, SAUDI ARABIA, SINGAPORE, SOUTH AFRICA, SWEDEN, SWITZERLAND, TUKEY, and UNITED KINGDOM.

    Quantity

    244