BEUDAMED
    FDA Enforcement Class II Terminated

    SOMATOM Confidence, Model Number 10590100 - 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-2272-2019 · Reported August 21, 2019

    Enforcement

    Recall Number
    Z-2272-2019
    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 Confidence, Model Number 10590100 - 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: 100172 100091 100112 100143 100158 100191 100107 100157 100137 100190 100092 100129 100136 100189 100156 100117 100097 100099 100174 100073 100016 100182 100146 100170 100175 100090 100160 100087 100025 100165 100147 100046 100140 100085

    Distribution

    US Nationwide distribution.

    Quantity

    N/A