BEUDAMED
    FDA Recall Terminated

    ECAT Emerge PET Scanners (distributed by Siemens Medical Solutions USA, Inc.), ECAT ART PET Scanners (distributed by Siemens Medical Solutions USA, Inc.) and Sceptre PET Scanners (distributed by Hitachi Medical Systems of America)

    Recall: Z-0712-06 · Initiated March 28, 2006

    Recall

    Recall Number
    Z-0712-06
    Event Number
    35001
    Firm
    Siemens Medical Solutions USA Inc
    FEI Number
    1034973
    Product Code
    KPS
    Status
    Terminated
    Root Cause
    Other
    Initiated
    March 28, 2006
    Posted
    April 4, 2006
    Terminated
    December 22, 2009
    Address
    810 Innovation Dr, Knoxville, TN, 37932-2562

    Description

    ECAT Emerge PET Scanners (distributed by Siemens Medical Solutions USA, Inc.), ECAT ART PET Scanners (distributed by Siemens Medical Solutions USA, Inc.) and Sceptre PET Scanners (distributed by Hitachi Medical Systems of America)

    Reason

    There is a potential for inaccurate, elevated SUVs (standardized uptake values). On follow-up scans, the elevated SUV could be misinterpreted, and inappropriately impact a patient's treatment plan.

    Action

    Written notification was sent out beginning 03/28/2006 to end users to advise them of the problem. The notification also included specific work instructions to aid the end user until the patch is available and the upgrade could be performed by a service representative.

    Distribution

    KS, WA, CA, OH, FL, TX, Germany, Great Britain, Canada Switzerland, Turkey, Argentina, Austria, France, & Spain

    Quantity

    57 devices