Public recall detail

TCM5 monitor

2024-11-06

medium
Recall Safety notice
Quick summary

Quick summary: TCM5 monitor. Date: 2024-11-06.

Recommended action

Recommended action: compare your product with the official notice and follow the instructions published by the official source.

Recall details

Quick summary: TCM5 monitor. Date: 2024-11-06.

Official details

Affected product details

Structured information extracted from the official recall notice. Confirm the identifiers and instructions in the original notice.

BrandRadiometer Medical Aps
ProductTCM5 monitor
IssueMedical devices - Performance
Recall classType II
IdentificationRA-76454

Affected products

ProductTcm5
Lotsoftware versions 1.5.0 software versions 1.5.0.1
Model393-500
Serial numbersoftware versions 1.5.0 software versions 1.5.0.1
DescriptionTcm5

Issue

Radiometer has become aware of an issue with the TCM5 monitor. The issue is that the TCM5 application may freeze and not update the display with new values or send new values to a central monitoring system. This means that the last measured values remain displayed unchanged on the screen of the TCM5 screen and in a central monitoring system and may not reflect patient status. For this reason, Radiometer requests that you stop using the affected product (except in sleep studies*), with immediate effect. *All TCM5 monitors with software versions 1.5.0 or 1.5.0.1 are affected. However, it has been assessed that if used in sleep studies, non-critical patients will not experience harm. Recall start date: October 22, 2024

What you should do

  • Contact the manufacturer if you require additional information.
Additional official information
AudienceHealthcare
CategoryHealth products - Medical devices - Cardiovascular
CompaniesRadiometer Medical Aps Akandevej 21, Bronshoj, Denmark, 2700
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-76454
Background{}
CompaniesRadiometer Medical Aps Akandevej 21, Bronshoj, Denmark, 2700
AudiencesHealthcare
Source updated2024-11-06

Contains information licensed under the Open Government Licence – Canada. SafetyPulse is independent of the Government of Canada.

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