| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-01416-1 |
| Product Name/Description |
Radiometer TCM5 transcutaneous blood gas monitor
ARTG Number:140333 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
2/11/2016 |
| Responsible Entity |
|
| Reason/Issue |
Radiometer has recently become aware that part of the specifications stated in the TCM5 Instructions for Use (IFU) for professionals for Tc Sensor 92 is incorrect.
The current IFU state incorrectly under “Combined effects of Linearity and hysteresis” the following:
- at 33 % CO2: better than 3 mmHg or 0.40 kPa
The correct statement is:
- at 33 % CO2: better than 5 mmHg or 0.67 kPa.
The above correction is not considered to be of clinical significance. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Radiometer is currently updating the Instructions for use and will distribute the updated version to customers when available. In the interim, users are notified of the update through the customer letter. This action has been closed-out on 23/06/2017. This action has been closed-out on 23/06/2017. |
| Contact Information |
1800 247 254 - TCM Product Manager |