BEUDAMED
    FDA Recall Terminated

    Siemens Medical Solutions USA, Inc., Symbia T Series SPECT-CT (Single-Photon Emission Computed Tomography and Computed Tomography) System.

    Recall: Z-0284-2012 · Initiated October 14, 2011

    Recall

    Recall Number
    Z-0284-2012
    Event Number
    60142
    Firm
    Siemens Medical Solutions USA, Inc.
    FEI Number
    1000514697
    Product Code
    JAK
    Status
    Terminated
    Root Cause
    Component change control
    Initiated
    October 14, 2011
    Posted
    November 23, 2011
    Terminated
    October 16, 2012
    Address
    2501 Barrington Rd, Hoffman Estates, IL, 60195-2061

    Description

    Siemens Medical Solutions USA, Inc., Symbia T Series SPECT-CT (Single-Photon Emission Computed Tomography and Computed Tomography) System.

    Reason

    Errors could potentially impact image interpretation. The acquisition software is exhibiting a defect in the energy window position when an isotope is peaked. There is a potential patient safety issue when running syngo MI Applications version VA60A with Foresight detectors firmware version v1.5.9.12 on the Symbia systems.

    Action

    Siemens Medical Solutions USA, Inc. sent an "Urgent Field Correction Recall" letter dated October 14, 2011 to all affected customers. The letters informed customers of the acquisition software defect in the energy window position when an isotope is peaked, which could potentially impact image interpretation, and that the AEB firmware version on their imaging system has been changed to a previously released version until acquisition software service pack is available. For questions or assistance they were instructed to contact Siemens Medical Solutions USA, Inc. at (800) 888-7436.

    Distribution

    Florida, Illinois and Texas

    Quantity

    3 units