Use caution Medical device recall · FDA · Published February 20, 2020

Radiometer TCM4 Base Unit Recall: Display Flickering May Delay Patient Monitoring

Radiometer recalls TCM4 Base units with specific serial numbers due to display flickering and monitor unresponsiveness, which could delay patient monitoring and compromise product performance.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1755-2020Medical device Radiometer ›

Use caution until it’s fixed

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.

Take action

Contact the company

Recalling firmRadiometer Medical ApSAkandevej 21 · Bronshoj, Denmark

✎ GovInfoNow plain-language explainer

Radiometer is recalling specific TCM4 Base units that may flicker or become unresponsive, potentially delaying patient monitoring and causing unsafe monitoring conditions. This affects medical devices used for pediatric and adult patient monitoring. Read more at govinfonow.com/recall/65803-radiometer-tcm4-base-unit-recall-display-flickering-may-delay-patient.

Source Summary by GovInfoNow · govinfonow.com/recall/65803-radiometer-tcm4-base-unit-recall-display-flickering-may-delay-patient · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1755-2020

Cite this page

“Radiometer TCM4 Base Unit Recall: Display Flickering May Delay Patient Monitoring.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/65803-radiometer-tcm4-base-unit-recall-display-flickering-may-delay-patient. Based on FDA recall #Z-1755-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1755-2020%22&limit=1).

The FDA announced on Feb. 20, 2020, that Radiometer Medical ApS is recalling TCM4 Base units due to display flickering or unresponsiveness that may delay patient monitoring. Owners should contact the company for a remedy.

How to tell if you have it

TCM4 Base unit, Ref 391-880
UDI: (01)05700693918808
UPC: 05700693918808
Used with monitor modules TCM4 (902-778), TCM40 (902-778, 902-946, or 902-862), TCM400 (902-564), TOSCA (903-044) and CombiM (903-111)
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
Sold worldwide including FL, KS, NY, ND, IN, TX, CA, VA, MA, MN, WI, CT, WA, China, India, Japan, and South Korea

The hazard

Reports indicate the transcutaneous monitoring system display may flicker or become non-responsive and beep. This issue may result in delayed patient monitoring and potentially compromise product performance.

Context

GovInfoNow's records show Radiometer Medical ApS has 16 other recalls on record since Feb. 27, 2018. Other recent recalls of similar products include Philips IntelliVue MX40: Patient Monitor May Not Alarm (Oct. 31, 2025), Philips IntelliVue Multi-Measurement Module X3 Recall: Monitor May Not Alarm (Oct. 31, 2025) and Philips Telemetry Monitor 5500 1.4 GHz Recall: Risk of Device Reset Causing Connection Failure (June 5, 2026).

How to tell if you have this one

Check if your TCM4 Base unit has the serial numbers listed in the recall notice (e.g., 391-880R0471N017). The device is used with specific monitor modules including TCM4, TCM40, TCM400, TOSCA, and CombiM models.

Brand
Radiometer
Product
TCM4 Base unit, Ref 391-880, UDI:(01)05700693918808, used with the monitor modules TCM4 (902-778), TCM40 (902-778
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Device Serial Number
Identify your TCM4 Base unit's serial number to see if it matches the affected list provided in the recall notice.
Contact Radiometer for Guidance
Reach out to Radiometer Medical ApS directly for further instructions on whether your device needs repair or replacement.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 13 states.

FDA 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.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: California, Connecticut, Florida, Indiana, Kansas, Massachusetts, Minnesota, New York, North Dakota, Texas, Virginia, Washington, Wisconsin.

Recall timeline

FDA terminated this recall 2.3 years after the firm started it.

Feb 20, 2020Firm started the recall
Apr 22, 2020FDA classified it Class II
Apr 29, 2020Published in FDA’s Enforcement Report
Jun 24, 2022FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

Similar recalls

Latest medical device recalls

Keep exploring

More Radiometer recalls

Link to this recall

<a href="https://govinfonow.com/recall/65803-radiometer-tcm4-base-unit-recall-display-flickering-may-delay-patient">Radiometer TCM4 Base Unit Recall: Display Flickering May Delay Patient Monitoring (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-1755-2020 (February 20, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1755-2020 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.