| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00105-1 |
| Product Name/Description |
Oxford Classic Floor Lifter
ARTG 397230
(Enable Lifecare Pty Ltd - Joerns Oxford Floor & Ceiling Hoist Range - Lift, patient transfer, mobile) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
16/02/2024 |
| Responsible Entity |
|
| Reason/Issue |
An unsecured fulcrum pin inevitably resulted in the hoist failing during use, culminating in an avoidable incident, lead to a serious adverse event. The user guide has been updated with information to ensure that the fulcrum pin is secured. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Customers are advised to read the updated user guide, and carefully ensure that the fulcrum pin is fully and securely inserted through the mating hole of the king pin when reassembled. |
| Contact Information |
Support@enablelifecare.com.au |