BEUDAMED
    FDA Recall Terminated

    PET/CT Software Versions MSV 1.0 and 1.1 used in the following PET (Positron Emission Tomography) and X-Ray Computed Tomography (CT) systems: Siemens Models: Biograph PET/CT CTI Models: Reveal PET/CT

    Recall: Z-0547-05 · Initiated May 27, 2004

    Recall

    Recall Number
    Z-0547-05
    Event Number
    30802
    Firm
    CTI PET Systems Inc
    FEI Number
    1034973
    Product Code
    KPS
    Status
    Terminated
    Root Cause
    Other
    Initiated
    May 27, 2004
    Posted
    February 16, 2005
    Terminated
    October 7, 2008
    Address
    810 Innovation Dr, Knoxville, TN, 37932-2562

    Description

    PET/CT Software Versions MSV 1.0 and 1.1 used in the following PET (Positron Emission Tomography) and X-Ray Computed Tomography (CT) systems: Siemens Models: Biograph PET/CT CTI Models: Reveal PET/CT

    Reason

    Misalignment of CT and PET scans from performing additional CT scans may produce an incorrect fused data set. In performing additional CT scans, the original PET and CT scans may become misaligned and produce an incorrect fused data set.

    Action

    Written notification was sent via letter on May 27, 2004 to the end users to alert the consignees of the problem. The corrective software was mailed on December 17, 2004.

    Distribution

    Nationwide, Germany, Spain, Italy, Korea and Canada