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.
What this means for you
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
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