TCM5 monitor
Brand(s)
Summary
Contact the manufacturer if you require additional information.
Affected products
Affected products |
Lot or serial number |
Model or catalogue number |
|---|---|---|
Tcm5 |
software versions 1.5.0 |
393-500 |
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
Additional information
Details
| Radiometer Medical Aps |
| Akandevej 21, Bronshoj, Denmark, 2700 |
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