BEUDAMED
    FDA Recall Open, Classified

    Sensis/ Sensis Vibe systems with software VD1X as follows: (1)Sensis Model 10764561 (2) Sensis Vibe Hemo Model 11007641 (3)Sensis Vibe Combo Model 11007642 Intended Use: A diagnostic and administrative tool supporting hemodynamic catheterizations and/or electrophysiology studies

    Recall: Z-0226-2022 · Initiated October 5, 2021

    Recall

    Recall Number
    Z-0226-2022
    Event Number
    88870
    Firm
    Siemens Medical Solutions USA, Inc
    FEI Number
    2240869
    Product Code
    MUQ
    Status
    Open, Classified
    Root Cause
    Software design
    Initiated
    October 5, 2021
    Address
    40 Liberty Blvd, Malvern, PA, 19355-1418

    Description

    Sensis/ Sensis Vibe systems with software VD1X as follows: (1)Sensis Model 10764561 (2) Sensis Vibe Hemo Model 11007641 (3)Sensis Vibe Combo Model 11007642 Intended Use: A diagnostic and administrative tool supporting hemodynamic catheterizations and/or electrophysiology studies

    Reason

    System operator manual states that the system should be rebooted once, every 7 days. In some cases, users are not following these instructions and the system is running for more than 7 days. Under rare circumstances, this may result in a partial freeze of the user interface which would no longer update the vital signs

    Action

    Siemens Medical Solutions USA, Inc. initiated a Customer Safety Advisory Notice to customers via AX067/21/S dated 10/5/21. Letter states reason for recall,health risk and action to take: The software in the affected systems will be updated to display a notification message. Once the system has reached a runtime of more than 7 days, a notification message will be displayed after closing a study to remind the operator to reboot the system as it is running longer than advised. In addition, the system operating manual will include a warning message that the Sensis system can have performance issues when running for more than 7 days nonstop without a restart. A system running nonstop for more than 7 days may display incorrect or delayed vital signs; the values may not be saved, the report generation may be incorrect, and the system could become unavailable before or during an examination. The warning message will also contain the statement that the Sensis system should be restarted at least once a week. Siemens will provide a software update for all affected systems which will be distributed via Update Instruction AX066/21/S. Our service organization will contact you shortly to arrange a date to perform this corrective action. Please feel free to contact our service organization for an earlier appointment 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

    Nationwide

    Quantity

    403 units