BEUDAMED
    FDA Recall Terminated

    Software versions syngo CT VB20 running on the following Siemens SOMATOM CT Scanner. SOMATOM Force (Model #10742326), SOMATOM Definition As (Model #8098027), SOMATOM Definition Edge (Model #10590000), SOMATOM Definition Flash (Model #10430603), SOMATOM Drive (Model #10431700), SOMATOM Confidence (Model #10590100), and SOMATOM Edge Plus (Model # 10267000) with software syngo CT VB20

    Recall: Z-0406-2020 · Initiated October 7, 2019

    Recall

    Recall Number
    Z-0406-2020
    Event Number
    84110
    Firm
    Siemens Medical Solutions USA, Inc
    FEI Number
    2240869
    Product Code
    JAK
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    October 7, 2019
    Terminated
    November 14, 2022
    Address
    40 Liberty Blvd, Malvern, PA, 19355-1418

    Description

    Software versions syngo CT VB20 running on the following Siemens SOMATOM CT Scanner. SOMATOM Force (Model #10742326), SOMATOM Definition As (Model #8098027), SOMATOM Definition Edge (Model #10590000), SOMATOM Definition Flash (Model #10430603), SOMATOM Drive (Model #10431700), SOMATOM Confidence (Model #10590100), and SOMATOM Edge Plus (Model # 10267000) with software syngo CT VB20

    Reason

    Software issue identified in the software versions syngo CT VB20 running on the SOMATOM CT Scanner: scan aborts and system crashes

    Action

    Siemens Medical Solutions USA, Inc. issued a Customer Safety Advisory Notice (CSAN) to all affected customers via CT070/19/S. on 10/719 via email/or letter. The CSAN provides recommendations to avoid the issues until the technical solution can be applied. The issues will be resolved with software update version syngo CT VB20_SP1 (Service Pack 1). You will receive the updated software free of charge. Questions or require technical support, please contact the service organization at 1-800-888-7436.

    Distribution

    Nationwide

    Quantity

    305 units