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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 Huntleigh Healthcare Pty Ltd
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.
Contact Information 1800 072 040 - Arjo Huntleigh