| TGA Action ID |
RC-2026-RN-00672-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
TCM Tosca and TCM CombiM
TCM4 Tosca
Model: 903-044
TCM4 CombiM
Model: 903-111
All Software Versions
All Serial Numbers
ARTG 167226 & 167250 (Cancelled) |
| ARTG Number |
|
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
Radiometer has become aware of a potential problem affecting the TCM Tosca and TCM CombiM monitors. Due to a software bug related to time and date calculations, the monitor may terminate an ongoing measurement and display “General Error” with an audible alert. When the general error occurs, the active measurement is terminated, resulting in an interruption or delay in transcutaneous monitoring.
The described error condition could inconvenience users and require multiple re-starts to clear the error. An interruption or delay in transcutaneous monitoring could lead to limited and temporary hypoxia or hyperoxemia. This risk may be mitigated by the alert sound that the device emits, the patient is being continuously monitored either by redundant monitoring systems or by continuous human presence.
To date, 37 complaints have been received regarding this problem. No harm has been reported as a consequence of any of the complaints. |
| Instructions for Customers/Users |
In case the monitor displays “General Error”:
- If available, switch to an alternative TC Tosca or TCM CombiM monitor.
- If an alternative is not available, restart the device. However, the error is likely to recur within a short timeframe, and you will need to restart the device each time the problem occurs.
Radiometer is developing updated software that will eliminate the potential timing error. This software is expected to be available before the end of September 2026. Once the software has been released, your Radiometer representative will contact you to arrange the upgrade of the software in your monitors. |
| Action Commencement Date |
7/09/2026 |
| Responsible Entity |
|
| Contact Information |
1800 247 254 - Radiometer |