BEUDAMED
    FDA Recall Terminated

    ICU Medical Cogent Hemodynamic Monitoring System, Cogent Item Number 58400-000, UDI: (01)00840619079499

    Recall: Z-1835-2020 · Initiated July 12, 2019

    Recall

    Recall Number
    Z-1835-2020
    Event Number
    85300
    Firm
    ICU Medical, Inc.
    FEI Number
    2025816
    Product Code
    DXQ
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    July 12, 2019
    Terminated
    May 10, 2023
    Address
    951 Calle, Amanecer San Clemente, CA, 92673-6212

    Description

    ICU Medical Cogent Hemodynamic Monitoring System, Cogent Item Number 58400-000, UDI: (01)00840619079499

    Reason

    Firm identified several software issues through internal testing of its Cogent Hemodynamic Monitoring System. These issues may result in inaccurate monitoring data, unit shutdown, and/or loss of display of a secondary parameter.

    Action

    Customers were notified of the recall via UPS letter on 7/12/2019. The firm is voluntarily notifying customers and will contact customers to schedule a software update once the updated software is available. The firm has instructed customers to use the mitigation instructions detailed in the customer letter to reduce the likelihood of the software conditions occurring. The firm also requested customers complete a response form and return it to the firm. For additional information or technical assistance contact ICU Medical at 1-866-829-9025, option 4.

    Distribution

    US Nationwide Distribution in the states of FL, WI, NY, NC, VT, IL, MD, CA, NE, WA OUS: None

    Quantity

    83 units