BEUDAMED
    FDA Recall Terminated

    SOMATOM CT System Sensation 40 and Sensation 64. Computed tomography x-ray system.

    Recall: Z-0795-06 · Initiated March 9, 2006

    Recall

    Recall Number
    Z-0795-06
    Event Number
    34872
    Firm
    Siemens Medical Solutions USA, Inc
    FEI Number
    2240869
    Product Code
    JAK
    Status
    Terminated
    Root Cause
    Other
    Initiated
    March 9, 2006
    Posted
    April 26, 2006
    Terminated
    July 19, 2006
    Address
    51 Valley Stream Pkwy, Malvern, PA, 19355-1406

    Description

    SOMATOM CT System Sensation 40 and Sensation 64. Computed tomography x-ray system.

    Reason

    When using the LungCare feature in the SOMATOM CT Systems some marks made on CT images may not be saved.

    Action

    The recalling firm has issued a software patch to the affected customers per Update Instructions CT086/05/S and CT087/05/S. By letter 3/9/2006. In addition, a Siemens Service Engineer will visit affected sites to install this software patch which will resolve this issue.

    Distribution

    Nationwide. The product was shipped to AK, AZ, CA, DE, FL, GA, IL, IN, KY, LA, MD, ME, MI, MT, NC, NY, OH, OK, PA, PR, TX, UT, VA, WA and WI.

    Quantity

    38 units