BEUDAMED
    FDA Recall 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 · Initiated February 14, 2019

    Recall

    Recall Number
    Z-1244-2019
    Event Number
    82227
    Firm
    Siemens Medical Solutions USA, Inc
    FEI Number
    2240869
    Product Code
    JAK
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    February 14, 2019
    Terminated
    May 1, 2020
    Address
    40 Liberty Blvd, Malvern, PA, 19355-1418

    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.

    Action

    Siemens issued letter dated 2/14/19 providing reason for recall and a user workaround in the Customer Safety Advisory Notice (CSAN) CT006/19/S. The recall issue will be permanently resolved by software update syngo CT VB10A_SP1. Contact the service organization 1-800-888-7436.

    Distribution

    US Nationwide Distribution

    Quantity

    53 total units distributed in U.S.