| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00566-1 |
| Product Name/Description |
Tenor without scale (Mobile patient transfer lift)
All devices manufactured since 2004, not equipped with scale
ARTG Number: 199602 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
20/05/2014 |
| Responsible Entity |
|
| Reason/Issue |
During use, the bolt in the connection between the spreader bar and the lifting arm jig is subjected to mechanical forces, which may lead to breakage. This is due to the design of the connection between spreader bar and lifting arm jig, which in long term use can cause metal fatigue in this part and the formation of micro-cracks in the thread of the bolt. This issue is only related to Tenor devices without scales. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
ArjoHuntleigh will arrange for the replacement of the old spreader bar with a new spreader with scales. This action has been closed-out on 12/02/2016. |
| Contact Information |
08 9314 4117 - ArjoHuntleigh |