BEUDAMED
    FDA Recall Terminated

    Symbia S Series SPECT (Single-Photon Emission Computed Tomography) System with a Pinhole Collimator; Siemens Medical Solutions USA, Inc., Molecular Imaging, 2501 N. Barrington Road, Hoffman Estates, IL 60195-5203 USA; part number 08717741

    Recall: Z-0548-2007 · Initiated January 30, 2007

    Recall

    Recall Number
    Z-0548-2007
    Event Number
    37231
    Firm
    Siemens Medical Solutions USA, Inc.
    FEI Number
    1000514697
    Product Code
    KPS
    Status
    Terminated
    Root Cause
    Other
    Initiated
    January 30, 2007
    Posted
    February 23, 2007
    Terminated
    November 30, 2007
    Address
    2501 Barrington Rd, Hoffman Estates, IL, 60195-2061

    Description

    Symbia S Series SPECT (Single-Photon Emission Computed Tomography) System with a Pinhole Collimator; Siemens Medical Solutions USA, Inc., Molecular Imaging, 2501 N. Barrington Road, Hoffman Estates, IL 60195-5203 USA; part number 08717741

    Reason

    Symbia systems, running on e.soft version 5.5 or earlier, could allow a fully-extended patient pallet to come into contact with the pinhole collimator, resulting in system damage.

    Action

    Siemens sent Customer Safety Advisory Notice/Urgent Field Correction Recall letters dated 1/30/07 to all users of Symbia systems with a pinhole collimator and e.soft software versions 5.5 or earlier. The accounts were informed of the potential for a fully-extended patient pallet to come into contact with the pinhole collimator, resulting in system damage. The customers were advised that a Siemens Customer Service Representative would be sent to their site to upgrade their system software to version syngeo MI Applications 2006A within 30 days. The upgrade will be done free of charge.

    Distribution

    Worldwide distribution --- including USA states of Alabama, California, Georgia, Indiana, Kentucky, Michigan, Ohio, Pennsylvania, Texas, Virginia and countries of Australia, Bolivia, Canada, China, France, Germany, Hong Kong and Spain.

    Quantity

    16 units