| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00617-1 |
| Product Name/Description |
MicroGas 7650 Operator Manual used with Radiometer MicroGas 7650 Transcutaneous Monitor
Serial Numbers: All lots
Affects: COMBI M sensor 82 ; Item code: 0605000
ARTG Number: 140334 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
9/07/2015 |
| Responsible Entity |
|
| Reason/Issue |
RADIOMETER has recently become aware that the storage temperature range for the COMBI M sensor 82 printed in the Operators Manual for MicroGas 7650 is incorrect. The Operators Manual states that the storage temperature range is -40C to +70C when it should be -10C to +50C as per the information supplied with the product. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Radiometer is reiterating instructions on how to verify the performance of the sensor. An addendum to the instructions for use is also being provided with the correct storage conditions. This action has been closed-out on 15/08/2016. |
| Contact Information |
1800 247 254 - Radiometer |