| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2018-RN-00297-1 |
| Product Name/Description |
Radiometer TCM5FLEX/BASIC
All Serial Numbers
ARTG Number:140333
(Radiometer Pacific - Transcutaneous blood gas monitor) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
13/04/2018 |
| Responsible Entity |
|
| Reason/Issue |
Radiometer has recently become aware that the Wi-Fi hardware incorporated in the TCM5 monitor is not compliant with respect to the requirements for radiated emission (Radio Equipment Directive 2014/53/EU).
Australian customers do not currently utilise the Wi-Fi option on these devices. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Radiometer is advising that they will be contacting affected users to arrange for the software to be upgraded on TCM5 to V1.2.0 which will disable the Wi-Fi hardware.
Customers have been supplied an updated IFU which removes reference to Wi-Fi as part of the correction undertaken for RC-2018-RN-00299-1
This action has been closed out on 25/10/2018 |
| Contact Information |
1800 247 254 - Radiometer Pacific |