BEUDAMED
    FDA Recall Open, Classified

    1. Sensis, material # 10764561; UDI: 04056869010137 2. Sensis Vibe Hemo, material # 11007641; UDI: 04056869010199 3. Sensis Vibe Combo, material # 11007642; UDI: 04056869010205 The Sensis recording system is a diagnostic and administrative tool supporting hemodynamic catheterizations and/or electrophysiology studies, for cardiac, interventional Radiology, and surgical studies.

    Recall: Z-0499-2022 · Initiated November 23, 2021

    Recall

    Recall Number
    Z-0499-2022
    Event Number
    89199
    Firm
    Siemens Medical Solutions USA, Inc
    FEI Number
    2240869
    Product Code
    DQK
    Status
    Open, Classified
    Root Cause
    Software design
    Initiated
    November 23, 2021
    Posted
    January 14, 2022
    Address
    40 Liberty Blvd, Malvern, PA, 19355-1418

    Description

    1. Sensis, material # 10764561; UDI: 04056869010137 2. Sensis Vibe Hemo, material # 11007641; UDI: 04056869010199 3. Sensis Vibe Combo, material # 11007642; UDI: 04056869010205 The Sensis recording system is a diagnostic and administrative tool supporting hemodynamic catheterizations and/or electrophysiology studies, for cardiac, interventional Radiology, and surgical studies.

    Reason

    Software error which affects Sensis Vibe Hemo, Sensis and Sensis Vibe Combo systems with software version VD12A, which could cause possible hazard to patients, operators, or other persons and equipment. Under certain sporadic circumstances, the CO (Cardiac Output) measurement using the Thermodilution method will temporarily no longer be possible.

    Action

    On November 23, 2021, Siemens Healthineers issued an Urgent Medical Device Correction notice to all users of Sensis Vibe Hemo systems, Sensis and Sensis Vibe Combo systems with software version VD12A. Please make sure that an alternative system can be used to provide treatment. Please notify and instruct accordingly all the staff at your organization who need to be aware of this notice and will comply with the recommendations therein. Siemens will provide a software update to all affected customers which will correct the issue via Update Instruction AX077/21/S. Siemens service organization will contact you to arrange a date to perform this corrective action. Please feel free to contact Siemens service organization for an earlier appointment at 1-800-888-7436.

    Distribution

    US Nationwide distribution in the states of AK, AL, AR, AZ, CA, FL, GU, HI, IA, IL, IN, KS, KY, MA, MI, MO, MS, NC, NE, NJ, NY, OH, OK,PA, PR, SD, TN, TX, WA, WV.

    Quantity

    1047