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Tcm5 monitor
Official notice
6 Nov 2024
Last checked
6 Nov 2024
An official Health Canada notice concerns Tcm5 monitor. 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 Published 2024-11-06.
What to do now
Contact the manufacturer if you require additional information.
Recall number
76454
Official notice
2024-11-06
The hazard
The hazard
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
How to check if you're affected
How to check if you're affected
Compare the product name and identifiers below with the item you own. Follow the official notice if they match.
Recall Numbers
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Affected products
Product 1
Risk / hazard
Where it was sold
Where it was sold
The source does not list specific retailers. See the official notice for where affected products were sold.
Location 1
Affected area 1
Company & contacts
Company & contacts
Brand: Radiometer Medical Aps, Tcm5 Monitor.
Source & status
Source & status
Source
Tier
Category
Classification
App estimate
Recall details
Recall details
Recall number
Classification
Source tier
Documents, notices & source
See the official notice and source documents for full details.
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