BEUDAMED
    FDA Recall Terminated

    Sensis / Sensis Vibe systems with software version VD12 and equipped with HP Flex Pro-C PC. Diagnostic and administrative tool supporting hemodynamic catheterizations and/or electrophysiology studies Model Numbers: Sensis Vibe Hemo 11007641 Sensis Vibe Combo 11007642 Sensis 10764561 Postprocessing Workstation 6648161 SIS Server 6648153

    Recall: Z-1173-2021 · Initiated January 27, 2021

    Recall

    Recall Number
    Z-1173-2021
    Event Number
    87273
    Firm
    Siemens Medical Solutions USA, Inc
    FEI Number
    2240869
    Product Code
    DQK
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    January 27, 2021
    Terminated
    October 25, 2021
    Address
    40 Liberty Blvd, Malvern, PA, 19355

    Description

    Sensis / Sensis Vibe systems with software version VD12 and equipped with HP Flex Pro-C PC. Diagnostic and administrative tool supporting hemodynamic catheterizations and/or electrophysiology studies Model Numbers: Sensis Vibe Hemo 11007641 Sensis Vibe Combo 11007642 Sensis 10764561 Postprocessing Workstation 6648161 SIS Server 6648153

    Reason

    System may sporadically freeze (lock-up) during operation or while being in an idle state, no longer possible to interact with the system

    Action

    Siemens issued Urgent Medical Device Correction via Customer Safety Advisory Notice AX010/21/S dated 1/27/21distributed to all affected customers. Additionally, a solution to eliminate the root cause of this problem is being distributed via Update Instruction AX009/21/S to all affected customers. Letter states reason for recall, health risk and action to take: The freeze is a total lock-up of the system and requires a power cycle of the PC to recover. Please make sure that an alternative system can be used to continue treatment in such cases.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. Following the correction, the cause is eliminated, and any recurrence of this potential fault is prevented. 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 in the states of AK, AR, CA, GU, IA, IL, MI, MO, NC, NE, OR, PA, PA, PR, SD, TN, TX, WA.

    Quantity

    37 US