| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-01199-1 |
| Product Name/Description |
Enterprise and Citadel Range Beds
Models: Enterprise 5000X with split safety side, Enterprise 8000X, Enterprise 9000X, Citadel and Citadel Plus
Serial Number Range: P0183010 – P0469078
ARTG Number: 283224
(Arjo Australia - Bed, general-purpose, electrical) |
| Recall Action Level |
Consumer |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
12/02/2018 |
| Responsible Entity |
|
| Reason/Issue |
Arjo Huntleigh has received customer complaints regarding the failure of gas spring (damper index no. 828.760) which did not support the safety sides properly. As a result, when safety sides are being lowered, the dampers do not slow down the movement of the side rail. In these circumstances, the dampers do not provide the correct distance between panels and the frame of the bed to ensure no entrapment of fingers.
|
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
ArjoHuntleigh will be in contact with users to arrange replacement of affected gas dampeners. In the interim, users are advised to refer to the IFU for details regarding processes for safe side rail lowering, including steps that the rail should be held until completely lowered.
This action has been reviewed and is considered complete in accordance with the requirements of the URPTG. |
| Contact Information |
1800 072 040 - Arjo Huntleigh |