| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-00902-1 |
| Product Name/Description |
Tecotherm Neo (a heating/cooling system for use with infants)
Serial numbers: 2016/11/10 and below
ARTG Number: 192036 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
20/07/2016 |
| Responsible Entity |
|
| Reason/Issue |
It has been identified that the self-test conducted immediately after switching on the device is evaluated as failed although everything would work correctly. Users would see a message that says a serious internal malfunction has occurred and after 30 seconds the device would automatically switch off. This is a result of a defect with the main circuit board. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Niche Medical is advising users that if the device starts up as normal, it is safe to continue to use. If the error occurs, it is recommended users use an alternative device or method.
Niche Medical will be implementing a software upgrade as a permanent correction. This action has been closed-out on 16/02/2017. |
| Contact Information |
1300 136 855 - Niche Medical |