BEUDAMED
    FDA Enforcement Class II Terminated

    SOMATOM Force, Model Number 10742326 - Product Usage: Computed tomography systems intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data. The images delivered by the system can be used by a trained physician as an aid in diagnosis. The images delivered by the system can be used by trained staff as an aid in diagnosis, treatment preparation and radiation therapy planning. These CT systems can be used for low dose lunch cancer screening in high risk populations (as defined by professional medical societies).

    Recall: Z-2274-2019 · Reported August 21, 2019

    Enforcement

    Recall Number
    Z-2274-2019
    Event ID
    83377
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Siemens Medical Solutions USA, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    August 21, 2019
    Initiation Date
    July 3, 2019
    Classification Date
    August 14, 2019
    Termination Date
    May 10, 2024
    Address
    40 Liberty Blvd, N/A, Malvern, PA, 19355-1418, United States

    Description

    SOMATOM Force, Model Number 10742326 - Product Usage: Computed tomography systems intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data. The images delivered by the system can be used by a trained physician as an aid in diagnosis. The images delivered by the system can be used by trained staff as an aid in diagnosis, treatment preparation and radiation therapy planning. These CT systems can be used for low dose lunch cancer screening in high risk populations (as defined by professional medical societies).

    Reason

    Potential for four safety-related software issues impacting systems utilizing syngo.CT software version VB10A which may result in a scan abort.

    Code Info

    Serial Numbers: 75765 75949 94851 75984 76019 75789 75512 75770 75600 75994 76046 75768 75974 75867 75510 75535 75820 75754 75755 75993 75916 75971 75893 75944 75540 76027 75980 75571 75848 75953 75885 75500 75973 75850 75527 75728 75939 75923 83819 76057 75450 75760 75806 75808 75476 75588 75931 75900 75981 75906 75602 75964 75804 75837 75787 75743 76010 76041 75936 75959 75905 75942 75941 75805 75884 76006 75919 76003 75913 76050 76016 75524 75778 75501 75570 75769 75983 75849 76000 75999 75976 76008 75616 75750 76001

    Distribution

    US Nationwide distribution.

    Quantity

    N/A