BEUDAMED
    FDA Recall Terminated

    SOMATOM Drive with software syngo.CT VB20 Model #10431700

    Recall: Z-0287-2022 · Initiated August 30, 2021

    Recall

    Recall Number
    Z-0287-2022
    Event Number
    88888
    Firm
    Siemens Medical Solutions USA, Inc
    FEI Number
    2240869
    Product Code
    JAK
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    August 30, 2021
    Terminated
    January 16, 2024
    Address
    40 Liberty Blvd, Malvern, PA, 19355-1418

    Description

    SOMATOM Drive with software syngo.CT VB20 Model #10431700

    Reason

    software syngo.CT VB20 in the installed base, with or without syngo.CT software versions VB20_SP1, SP2, SP3, or SP4, may result in workflow interruptions resulting in the delay in diagnosis, the necessity for patient rescans, and/or the need for additional contrast media may occur

    Action

    Siemens Medical Solutions USA, Inc. initiated a Customer Safety Advisory Notice (CSAN) to customers via CT021/21/S on 8/30/2021. The CSAN informs the customer of the issues health risk, the new software update version VB20_SP5 to eliminate the root causes of these problems. The software update will be distributed free of charge via CT020/21/S and CT071/21/S (update is dependent on the current software version) to all affected customers. Action to take: Siemens Healthineers has developed software update syngo.CT VB20 SP5. This new software contains workflow improvements and solutions to the previously described software issues. Please ask your local service organization if you are interested in more detailed information about the content of the software update. The new software, VB20_SP5, will be provided free of charge and will be distributed via Update CT020/21/S or CT071/20/S. Update CT071/20/S is only necessary if the system is being updated from software version VB20, VB20_SP1, or VB20_SP2 directly to VB20_SP5. Following the corrective action process CAPA, the cause of identified product issues has been eliminated and a recurrence of the identified issues is prevented. This update will be performed remotely. The remote software updates process will require approximately 45 minutes 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. If you have any questions, please contact our service organization at at 1-800-888-7436. Please review, understand, and confirm acknowledgement of the information and instructions outlined in this Urgent Safety Advisory Notice. By signing this document, you are acknowledging that you have read and understand the content therein

    Distribution

    US Nationwide distribution.

    Quantity

    75 units