BEUDAMED
    FDA Enforcement Class II Terminated

    SOMATOM Definition Edge, Model Number 10590000 - 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-2269-2019 · Reported August 21, 2019

    Enforcement

    Recall Number
    Z-2269-2019
    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 Definition Edge, Model Number 10590000 - 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: 83904 83931 83834 83746 83811 83915 83801 83767 83880 83899 83852 83798 83837 83878 83832 83871 83903 83808 83763 75475 83732 83752 83382 83845 83846 83749 83847 83786 83842 83775 83796 94801 83768 83909 83875 83859 83928 83826 83754 83913 83896 83790 83824 83898 83810 83886 83758 83901 83914 83823

    Distribution

    US Nationwide distribution.

    Quantity

    N/A