BEUDAMED
    FDA Recall Terminated

    Siemens ECAT EXACT HR+, Catalog No. 3548083, PET/CT Scanner, Manufactured by Siemens Medical Solutions USA, Inc., 810 Innovation Drive, Knoxville, TN 37932 USA, TEL: 865-218-2534

    Recall: Z-0273-2008 · Initiated July 23, 2007

    Recall

    Recall Number
    Z-0273-2008
    Event Number
    45154
    Firm
    Siemens Medical Solutions USA Inc
    FEI Number
    1034973
    Product Code
    KPS
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    July 23, 2007
    Posted
    November 29, 2007
    Terminated
    September 11, 2009
    Address
    810 Innovation Dr, Knoxville, TN, 37932-2562

    Description

    Siemens ECAT EXACT HR+, Catalog No. 3548083, PET/CT Scanner, Manufactured by Siemens Medical Solutions USA, Inc., 810 Innovation Drive, Knoxville, TN 37932 USA, TEL: 865-218-2534

    Reason

    Incorrect Data Results - ECAT System's software versions 7.2.2 and 7.4 may calculate the decay correction for emission data incorrectly while performing whole-body studies with all transmissions followed by all emissions.

    Action

    Siemans sent an Urgent Device Correction letter, dated June 15, 2007, to all affected consignees informing the user of the problem and requesting that they discontinue the practice of running all transmissions followed by all emissions until a corrective software patch is installed. The corrective software patch is expected to be installed by October 2007.

    Distribution

    Worldwide Distribution - USA and Countries of Argentina, Austria, Belgium, Brazil, Canada, Switzerland, Chile, China, Czech Republic, Germany, Denmark, Spain, Finland, France, Great Britain, Italy, Japan, South Korea, Netherlands, Norway, Saudi Arabia, Sweden, Slovak Republic, Turkey, and Taiwan.

    Quantity

    117 units