BEUDAMED
    FDA Recall Terminated

    Biograph 6, Biograph PET/CT Scanner, Catalog No. 8728854, Manufactured by Siemens Medical Solutions USA, Inc., 810 Innovation Drive, Knoxville, TN 37932 USA, TEL: 865-218-2534

    Recall: Z-0249-2008 · Initiated July 23, 2007

    Recall

    Recall Number
    Z-0249-2008
    Event Number
    45153
    Firm
    Siemens Medical Solutions USA Inc
    FEI Number
    1034973
    Product Code
    KPS
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    July 23, 2007
    Posted
    January 4, 2008
    Terminated
    September 11, 2009
    Address
    810 Innovation Dr, Knoxville, TN, 37932-2562

    Description

    Biograph 6, Biograph PET/CT Scanner, Catalog No. 8728854, Manufactured by Siemens Medical Solutions USA, Inc., 810 Innovation Drive, Knoxville, TN 37932 USA, TEL: 865-218-2534

    Reason

    Visual asymmetric appearance; An asymmetry can be introduced into the attenuation-corrected PET images when using iterative reconstruction in combination with a specific number of subsets and reconstruction matrix sizes. (This problem only occurs when using protocols other than the default Biograph protocols)

    Action

    A certified letter-Urgent Device Correction- dated June 15, 2007 was sent to all affected consignees on July 23, 2007 informing them of the problem (PET iterative reconstruction algorithm) and requesting as a short term fix that they discontinue the practice of operating using protocols other than the default Biograph. Software upgrades as the long term fix were promised in the Urgent Device Correction Notice. Updated information received October 4, 2007: a software patch to fix PETsyngo 5.0 was released, software patch to fix PETsyngo 4.x was released, and target date for the software patch to fix PETsyngo 3.2 and 3.4 is the end of November 2007.

    Distribution

    Worldwide-USA and countries of Argentina, Austria, Australia, Belgium, Brazil, Canada, Switzerland, Chile, China, Czech Republic, Germany, Denmark, Spain, France, Great Britain, Hong Kong, Hungary, Ireland, India, Italy, Japan, South Korea, Kuwait, Lebanon, Mexico, Malaysia, Netherlands, Norway, Poland, Portugal, Sweden, Singapore, Slovak Republic, Thailand, Turkey, and Taiwan.

    Quantity

    175 units