CLASS II Device recall · Reported 29 Apr 2020 · FDA Enforcement Report

TCM4 Base unit recalled by Radiometer Medical ApS

Radiometer Medical ApS is recalling TCM4 Base unit, distributed nationwide in the US. The recall was initiated on 20 Feb 2020 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesAffected 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,

Quantity recalled84 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1755-2020
FDA event ID: 85257
Recalling firm: Radiometer Medical ApS, Bronshoj, N/A
Classification: Class II
Status: Terminated
Recall initiated: 20 Feb 2020
FDA classified: 22 Apr 2020
Reported: 29 Apr 2020
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Patient Monitors

Timeline

20 Feb 2020	Recall initiated by company
22 Apr 2020	Classified by FDA	+62 days
29 Apr 2020	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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.

Product as listed by the FDA

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.

Where it was distributed

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.

Nationwide California Connecticut Florida Indiana Kansas Massachusetts Minnesota North Dakota New York Texas Virginia Washington Wisconsin

Questions about this recall

Is TCM4 Base unit recalled?

Yes. Radiometer Medical ApS recalled TCM4 Base unit on 20 Feb 2020. The recall is Class II and its status is Terminated. Recall number Z-1755-2020.

Why was it recalled?

Which lots are affected?

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,

Where was it sold?

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.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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