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.

    Recall: Z-1244-2019 · Reported May 8, 2019

    Enforcement

    Recall Number
    Z-1244-2019
    Event ID
    82227
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Siemens Medical Solutions USA, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 8, 2019
    Initiation Date
    February 14, 2019
    Classification Date
    May 2, 2019
    Termination Date
    May 1, 2020
    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.

    Reason

    Potential risk of scans being aborted when using the optional Dual Spiral Dual Engery mode due to a software issue found in syngo CT VB10A for the Siemens Healthineers CT scanners with a single X-ray tube.

    Code Info

    Serial numbers of all affected models: 122022 100143 100107 83834 83746 83811 66649 122020 83801 122008 122029 83767 83852 100092 83798 100091 100112 100129 100136 83837 122023 83871 100117 100097 100099 122009 83763 83819 83752 83845 83846 83749 83847 100146 83786 83842 83775 100090 83796 83768 83859 100087 83826 83754 83790 122011 83824 100147 83810 83758 100140 100085 83808

    Distribution

    US Nationwide Distribution

    Quantity

    53 total units distributed in U.S.