BEUDAMED
    FDA Recall Terminated

    Software versions syngo.CT VB20 or VB20_SP1 in the following systems: 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)

    Recall: Z-3025-2020 · Initiated June 22, 2020

    Recall

    Recall Number
    Z-3025-2020
    Event Number
    86360
    Firm
    Siemens Medical Solutions USA, Inc
    FEI Number
    2240869
    Product Code
    JAK
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    June 22, 2020
    Posted
    September 28, 2020
    Terminated
    March 9, 2021
    Address
    40 Liberty Blvd, Malvern, PA, 19355

    Description

    Software versions syngo.CT VB20 or VB20_SP1 in the following systems: 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)

    Reason

    Sporadic problems with the current software may result in scanning workflow interruptions and unexpected user notifications causing delay in diagnosis or patient rescan

    Action

    Siemens Medical Solutions USA, Inc. has initiated a Customer Information Letter (CIL) to affected customers via CT004/20/S. The letter alerts customers of the technical issues and under what circumstances they may occur and health risk These issues will be resolved with software update version syngo CT VB20_SP2 (Service Pack 2) via UI CT003/20/S. The software update is being made available to all affected customers free of charge. If your system is connected to Siemens Remote Connection, this update will be performed remotely. The remote software update process will require approximately 2 hours for completion and is completely automatic; however, please make sure the system and power are stable before and during the process, please do not switch off the system during the update process. Siemens highly recommends starting the installation when the scanner will not be in use or when the necessary time for the update to be completed can be scheduled. your system is not connected to the Siemens Remote Connection, your Siemens Customer Service Engineer will schedule an appointment to perform the software update onsite. If you have any questions, please contact our service organization at 1-800-888-7436.

    Distribution

    Nationwide

    Quantity

    767 distributed in U.S.