BEUDAMED
    FDA Recall Terminated

    SOMATOM Force, System x-ray, tomography, computed

    Recall: Z-0692-2017 · Initiated October 20, 2016

    Recall

    Recall Number
    Z-0692-2017
    Event Number
    75594
    Firm
    Siemens Medical Solutions USA, Inc
    FEI Number
    2240869
    Product Code
    JAK
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    October 20, 2016
    Posted
    December 2, 2016
    Terminated
    May 30, 2017
    Address
    40 Liberty Blvd, Malvern, PA, 19355-1418

    Description

    SOMATOM Force, System x-ray, tomography, computed

    Reason

    Siemens is providing software update version VA50A_SP3 to address the software bugs that were identified through normal field monitoring and the Global Complaint Handling Process. Correction for the problems are as follows: 1. Correction to volumetric misrepresentations of high contrast objects when using ADMIRE. 2. Correction to highly sporadic scan aborts due to temporarily tube currents at 0mA. 3. Correction to missing Microsoft Hotfixes (MS16-001, MS15-135, MS15-088, MS15-048). 4. Correction to highly sporadic image artifacts caused by error signals from high voltage chain at extremely high tube currents. 5. Correction to highly sporadic incomplete image reconstruction due to temporary slow hard disk write speed. 6. Correction to highly sporadic scan aborts due to temporarily high disk load of system disk. 7. Correction to highly sporadic image artifacts generated by scatter correction in case of tube arcings.

    Action

    Siemens sent a Customer Information Letter dated November 2, 2016, to customers affected by the recall to inform them of a release of a software update that will provide bug-fixes to improve system performance. Customers will be contacted to arrange a date for onsite installation. For further questions, please call (610) 448-6471.

    Distribution

    Nationwide Distribution.

    Quantity

    48 units distributed in U.S.