BEUDAMED
    FDA Enforcement Class II 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 · Reported November 20, 2019

    Enforcement

    Recall Number
    Z-0406-2020
    Event ID
    84110
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Siemens Medical Solutions USA, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    November 20, 2019
    Initiation Date
    October 7, 2019
    Classification Date
    November 14, 2019
    Termination Date
    November 14, 2022
    Address
    40 Liberty Blvd, N/A, Malvern, PA, 19355-1418, United States

    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

    Code Info

    Software versions syngo CT VB20

    Distribution

    Nationwide

    Quantity

    305 units