BEUDAMED
    FDA Enforcement Class II 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 · Reported April 29, 2020

    Enforcement

    Recall Number
    Z-1755-2020
    Event ID
    85257
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Radiometer Medical ApS
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 29, 2020
    Initiation Date
    February 20, 2020
    Classification Date
    April 22, 2020
    Termination Date
    June 24, 2022
    Address
    Akandevej 21, N/A, Bronshoj, N/A, N/A, Denmark

    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.

    Code Info

    Affected Serial Numbers: 391-880R0471N017, 391-880R0471N030, 391-880R0473N006, 391-880R0473N016, 391-880R0471N021, 391-880R0472N010, 391-880R0473N007, 391-880R0471N022, 391-880R0472N011, 391-880R0473N008, 391-880R0471N023, 391-880R0472N014, 391-880R0473N009, 391-880R0471N024, 391-880R0472N016, 391-880R0473N010, 391-880R0471N025, 391-880R0472N020, 391-880R0473N011, 391-880R0471N026, 391-880R0473N001, 391-880R0473N020, 391-880R0471N027, 391-880R0473N002, 391-880R0473N013, 391-880R0471N028, 391-880R0473N003, 391-880R0473N014, 391-880R0471N029, 391-880R0473N005, 391-880R0473N015,

    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