BEUDAMED
    FDA Enforcement Class II Terminated

    SOMATOM Force, System x-ray, tomography, computed

    Recall: Z-0692-2017 · Reported December 14, 2016

    Enforcement

    Recall Number
    Z-0692-2017
    Event ID
    75594
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Siemens Medical Solutions USA, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 14, 2016
    Initiation Date
    October 20, 2016
    Classification Date
    December 2, 2016
    Termination Date
    May 30, 2017
    Address
    40 Liberty Blvd, N/A, Malvern, PA, 19355-1418, United States

    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.

    Code Info

    Model Number 10742326, Serial Numbers: 75708,75709,75607,75617,75550,75526 75512,75567,75536,75711,75514,75600,75563,75510,75454,75540,75571,75500 75527,75475,75535,75481,75482,75710,75460,75476,75588,75493,75458,75528 75467,75602,75487,75464,75478,75604,75513,75532,75555,75524,75515,75559 75610,75501,75570,75616,75576,75605

    Distribution

    Nationwide Distribution.

    Quantity

    48 units distributed in U.S.