Official recall record
TCM5 monitor
- Issuing authority
- Health Canada — Medical Devices
- Published
- 2024-11-06
- Country of alert
- Canada
- Alert level
- Type II
- Alert type
- recall
What the authority reported
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 to do
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Record last checked against the registry on 2026-05-31.