| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-00516-1 |
| Product Name/Description |
Carina Mobile Lifts
All Models and Series
ARTG Number: 144735 |
| Recall Action Level |
Consumer |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
12/05/2017 |
| Responsible Entity |
|
| Reason/Issue |
The manufacturer, Handicare, has identified the possibility that the Carina mobile lift could be mounted incorrectly by users in two respects. Namely, the lift arm and actuator could be incorrectly mounted and/or the mast with lift arm could be incorrectly mounted.
If the connection between lift arm and actuator is incorrectly mounted, there is a possibility that a metal part on top of the actuator (i.e. piston rod eye flange) fractures when subjected to certain weight loads. In the event that the mast is not fully inserted into the mast base and standing upright in a vertical position, there is a possibility that the mast falls forward when subjected to weight load. Therefore, there is a risk that an incorrectly mounted mobile lift would cause injury upon use. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Active Medical Supplies is requesting users to follow the additional instructions regarding the inspection of the connection between the lift arm and actuator as well as the positioning of the mast to prevent incorrect mounting of the mobile lifts. The instructions are contained in Annexes A and B (respectively) of the recall notification and are intended to supplement the Instructions for Use (IFU). Users are advised that the updated IFU is available for download from the manufacturer's website.
This action has been closed out on the 22/11/2018. |
| Contact Information |
07 3899 8887 - Active Medical Supplies |