Radiometer TCM4 Base Unit Recalled for Display Flickering and Unresponsiveness
Radiometer Medical ApS is recalling 84 TCM4 Base units due to reports of display flickering and unresponsiveness, which may delay patient monitoring.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a risk of harm (delayed monitoring) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Radiometer Medical ApS is recalling 84 units of the TCM4 Base unit (Ref 391-880) used with various monitor modules for pediatric and adult patients. The recall is due to reports that the transcutaneous monitoring system display may flicker or the monitor may become non-responsive and beep.
These issues may result in delayed patient monitoring and potentially compromise the product's performance. The affected units were distributed worldwide, including in the United States and several other countries.
Healthcare providers should stop using the affected units and contact Radiometer Medical ApS for instructions on repair or replacement. Consumers should check their device serial numbers against the list provided in the official recall notice to determine if their unit is affected.
The recalled product
- Product
- 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.
- Manufacturer
- Radiometer Medical ApS
- Affected units
- 84
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
Distribution
Related recalls
Same manufacturer · Radiometer Medical ApS
See all →- ModerateRadiometer ABL90 Series Blood Analyzers May Unexpectedly Freeze
FDA (Devices) · 2025-04-30
- HighABL800 FLEX Blood Gas Analyzers May Report Inaccurate pH Results
FDA (Devices) · 2024-07-31
- HighRadiometer AQURE Software Recall Due to Patient Mix-up Risk
FDA (Devices) · 2023-04-26
- HighABL800 Flex Analyzer Recalled for Potential Measurement Bias
FDA (Devices) · 2022-07-13
- HighRadiometer Arterial Blood Sampler recalled due to sterility guarantee loss
FDA (Devices) · 2022-05-25
Same hazard · device malfunction
See all →- SevereMedtronic MiniMed Flex Insulin Pumps Recalled for Failed Verification Tests
FDA (Devices) · 2026-10-14
- ModerateWilson-Cook Recalls Hemospray Endoscopic Hemostat Due to Adherence Issues
FDA (Devices) · 2026-09-23
- HighDatex-Ohmeda Aisys CS2 Anesthesia Systems Recalled for Gas Mixer Defect
FDA (Devices) · 2026-09-23
- HighDatex-Ohmeda Aisys CS2 Anesthesia Systems Recalled for Gas Mixer Defect
FDA (Devices) · 2026-09-23
- HighDatex-Ohmeda Et Control Software Recalled for Anesthetic Delivery Interruption
FDA (Devices) · 2026-09-23
Similar recalls
- ModerateRadiometer TCM4 Base Units Recalled for Electrical Safety Non-Compliance
FDA (Devices) · 2013-08-14
- ModerateRadiometer TCM CombiM Modules Recalled for Alarm Volume Error
FDA (Devices) · 2016-05-11
- HighRadiometer ABL90 FLEX PLUS Analyzer Recalled Due to Barcode Misinterpretation
FDA (Devices) · 2020-04-29
- ModerateRadiometer Fixation Kit N20 Recalled for Paper Coating Transfer
FDA (Devices) · 2015-08-26
- HighRadiometer ABL90 FLEX Analyzer Recalled for Barcode Reader Error
FDA (Devices) · 2020-04-29
- HighPhilips Efficia CMS200 Central Monitoring System Recalled for Pediatric Alarm Defect
FDA (Devices) · 2017-03-01