BEUDAMED
    FDA Recall Terminated

    The Cogent Hemodynamic Monitoring System. REF58400-000, GTIN 00840619099459; REF 58400-000R, GTIN 0087709094314; REF 58403, GTIN 00840619079505; REF 58401, GTIN 00840619079499 - Product Usage: intended for patients for whom the monitoring of continuous cardiac output and calculated hemodynamic parameters is indicated for diagnostic and prognostic evaluation by a clinician. The target population includes Critical Care Patients, Trauma Patients, and Cardiac Surgery Patients.

    Recall: Z-1927-2020 · Initiated February 14, 2020

    Recall

    Recall Number
    Z-1927-2020
    Event Number
    85329
    Firm
    ICU Medical, Inc.
    FEI Number
    2025816
    Product Code
    DXG
    Status
    Terminated
    Root Cause
    Software Design Change
    Initiated
    February 14, 2020
    Terminated
    May 3, 2023
    Address
    951 Calle, Amanecer San Clemente, CA, 92673-6212

    Description

    The Cogent Hemodynamic Monitoring System. REF58400-000, GTIN 00840619099459; REF 58400-000R, GTIN 0087709094314; REF 58403, GTIN 00840619079505; REF 58401, GTIN 00840619079499 - Product Usage: intended for patients for whom the monitoring of continuous cardiac output and calculated hemodynamic parameters is indicated for diagnostic and prognostic evaluation by a clinician. The target population includes Critical Care Patients, Trauma Patients, and Cardiac Surgery Patients.

    Reason

    Firm identified software issues which leads to the patient ID and patient information not being stored in the system.

    Action

    On 14 February 2020, the firm sent notification of the recall to direct consignees of record. Delivery will be confirmed via traceable mailing. All consignees who further distributed the product were asked to notify their customers

    Distribution

    US Nationwide distribution including in the states of AR, CA, FL, IL, MD, NC, NE, NY, TX, VT, WA and WI.

    Quantity

    123 units