Events

Recall of Enterprise and Citadel Range BedsModels: Enterprise 5000X with split safety side, Enterprise 8000X, Enterprise 9000X, Citadel and Citadel Plus

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Huntleigh Healthcare Pty Ltd.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    RC-2017-RN-01199-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2018-02-12
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01199-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • Extra notes in the data
  • Reason
    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.
  • Action
    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.

Device

Enterprise and Citadel Range BedsModels: Enterprise 5000X with split safety side, Enterprise 8000...
  • Model / Serial
    Enterprise and Citadel Range BedsModels: Enterprise 5000X with split safety side, Enterprise 8000X, Enterprise 9000X, Citadel and Citadel PlusSerial Number Range: P0183010 – P0469078ARTG Number: 283224(Arjo Australia - Bed, general-purpose, electrical)
  • Manufacturer
    Huntleigh Healthcare Pty Ltd

Manufacturer

Huntleigh Healthcare Pty Ltd
  • Manufacturer Parent Company (2017)
    Getinge AB
  • Source
    DHTGA