| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2018-RN-00230-1 |
| Product Name/Description |
Entroy Pool Lifter
Model Number: GAB1000-x01
Serial Numbers 810000957 up to T3387
ARTG Number: 230595
(Arjo Australia - Lift, patient transfer, stationary) |
| Recall Action Level |
Retail |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
26/03/2018 |
| Responsible Entity |
|
| Reason/Issue |
Arjo have identified a potential for the chair or stretcher detachment from Entroy pool lifter. It is identified that this issue is caused by a potential misalignment that might be unnoticed by the caregiver so the seat/stretcher does not get fully paired with the pin. Instead, once the lift reaches certain height, the seat/stretcher falls off the lift. There are one or more possible reasons that can lead to such a situation to occur:
- Maintenance checks not performed properly,
- Users do not recognize the poor connection,
- Pool lift owners do not recognise that the product needs maintenance,
- Wear on the docking connection causes the pin to hit the edge of the pairing cylinder instead of entering it. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Arjo are advising users that they will arrange for an on-site service technicians visit to install a Quick Reference Guide, which is an illustration-based instruction, which users may refer to in order to ensure patient transfer is conducted as indicated in the IFU.
This action has been closed out on 15/01/2019 |
| Contact Information |
1800 009 077 - Customer Service Centre |