| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-01264-1 |
| Product Name/Description |
Radiometer TCM5 Flex Monitor (non-invasive blood gas monitor)
Serial Numbers: below 393-500R0030N009
ARTG Number: 140333 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
23/09/2016 |
| Responsible Entity |
|
| Reason/Issue |
Radiometer has recently become aware of a potential risk that the TCM5 monitor may not be compliant with the waterproof specification, IPX2, which is required for a homecare environment. The problem is caused by incorrect assembly and may allow water to enter into the monitor, which may pose a risk of electrical shock for the user. There have been no reports of injuries as a result of this issue. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Radiometer is advising users to stop use of the affected devices until they have been inspected and repaired where required by a Radiometer representative. A loan unit will be provided while the device is being repaired. This action has been closed-out on 17/05/2017. |
| Contact Information |
1800 247 254 - Radiometer |