BEUDAMED
    FDA Recall Terminated

    Siemens Sensis Vibe Hemo system in combination with the MicroPodTM EtCO2 module-diagnostic and administrative tool supporting hemodynamic catheterization and/or electrophysiology studies, for cardiac as well as interventional Radiology.

    Recall: Z-2921-2020 · Initiated July 24, 2020

    Recall

    Recall Number
    Z-2921-2020
    Event Number
    86179
    Firm
    Siemens Medical Solutions USA, Inc
    FEI Number
    2240869
    Product Code
    DQK
    Status
    Terminated
    Root Cause
    Process design
    Initiated
    July 24, 2020
    Posted
    August 28, 2020
    Terminated
    November 2, 2021
    Address
    40 Liberty Blvd, Malvern, PA, 19355

    Description

    Siemens Sensis Vibe Hemo system in combination with the MicroPodTM EtCO2 module-diagnostic and administrative tool supporting hemodynamic catheterization and/or electrophysiology studies, for cardiac as well as interventional Radiology.

    Reason

    The connector linking the EtCO2 module to the HemoBox may break and become damaged, if the connector is re-attached to the HemoBox in this damaged state, under certain incorrect pin alignment conditions, the HemoBox may stop functioning and all vital signs are lost

    Action

    Siemens issued Customer Safety Advisory Notice distributed dated July 24 2020 to customers via AX048/20/S. Letter states reason for recall, health risk and action to take: If the connector linking the EtCO2 module to the HemoBox should become damaged or break, the operator shall not attempt to fix the connector or re-connect the cable to the HemoBox. Only Siemens Customer Service representative or a service provider authorized by Siemens Healthineers may resolve the issue. Siemens strongly recommends that you do not attempt to fix the connector or re-connect the cable to the HemoBox until the problem has been corrected by a service engineer. Siemens is currently developing a solution to eliminate the root cause of this problem. Our service organization will contact you when a solution has been initiated to arrange a date to perform this corrective action. Please feel free to contact our service organization at 1-800-888-7436. Following the correction, the cause will be eliminated, and any recurrence of this potential fault is prevented.

    Distribution

    US Nationwide distribution.

    Quantity

    110 units US