BEUDAMED
    FDA Recall Terminated

    TCM4 Base unit, Ref 391-880, UDI:(01)05700693918808, used with the monitor modules TCM4 (902-778), TCM40 (902-778, 902-946 or 902-862), TCM400 (902-564), TOSCA (903-044) and CombiM (903-111) - Product Usage: It is indicated for use on pediatrics and adults.

    Recall: Z-1755-2020 · Initiated February 20, 2020

    Recall

    Recall Number
    Z-1755-2020
    Event Number
    85257
    Firm
    Radiometer Medical ApS Akandevej 21 Bronshoj Denmark
    FEI Number
    3002807968
    Product Code
    LKD
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    February 20, 2020
    Terminated
    June 24, 2022

    Description

    TCM4 Base unit, Ref 391-880, UDI:(01)05700693918808, used with the monitor modules TCM4 (902-778), TCM40 (902-778, 902-946 or 902-862), TCM400 (902-564), TOSCA (903-044) and CombiM (903-111) - Product Usage: It is indicated for use on pediatrics and adults.

    Reason

    Reports have been received about the transcutaneous monitoring system display flickering or monitor becoming non responsive and beeping. This may result in delayed patient monitoring as well as potentially compromise the product performance.

    Action

    On February 20, 2020, a "Urgent: Medical device Recall" letter was sent to affected consignees via E-Mail and FedEx 2nd day delivery. In addition to informing consignees about the recall, the customer notification asked customers to take the following actions: 1. Cease using the affected TCM4 Base unit and put it on quarantine. 2. Complete the Recall Response Form (last page of this letter) and submit to your Radiometer representative. 3. Your Radiometer representative will exchange the computer hardware of your TCM4 Base unit as soon as possible when we receive replacement components. 4. If you are not the end-user of the affected product, please ensure that this letter is distributed to the final end-users. 5. If you have any questions, please contact us at 1-800-736-0600 option 1, Monday Friday 9am EST to 7pm EST

    Distribution

    Worldwide distribution - US Nationwide distribution including the states of FL, KS, NY, ND, IN, TX, CA , VA, MA, MN, WI, IN, CT, WA and the countries of China, India, Japan, south Korea.

    Quantity

    84 units