BEUDAMED
    FDA Enforcement Class II Terminated

    SOMATOM Force, Definition AS, Definition Edge, Definition Flash, Drive, Confidence and Edge Plus

    Recall: Z-0771-2021 · Reported January 20, 2021

    Enforcement

    Recall Number
    Z-0771-2021
    Event ID
    87079
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Siemens Medical Solutions USA, Inc
    Voluntary / Mandated
    FDA Mandated
    Initial Notification
    Letter
    Report Date
    January 20, 2021
    Initiation Date
    November 24, 2020
    Classification Date
    January 9, 2021
    Termination Date
    February 6, 2024
    Address
    40 Liberty Blvd, N/A, Malvern, PA, 19355, United States

    Description

    SOMATOM Force, Definition AS, Definition Edge, Definition Flash, Drive, Confidence and Edge Plus

    Reason

    System does not trigger a cancel command followed by a reload of the scan with the new parameter(s). This issue may result in a delay in diagnosis and/or need for patient rescan

    Code Info

    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) SOMATOM Edge Plus (Model #10267000) Siemens SOMATOM CT scanner systems with software syngo.CT VB20A_SP2.

    Distribution

    US Nationwide

    Quantity

    3044