Events

Recall of Contoura 1000 and 1080 Beds (used to facilitate management of very obese patients)

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-2013-RN-01040-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2013-10-09
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-01040-1
  • 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
    There is a low but existing entrapment risk for a patient being treated of this bed while being under a bmi of 40. small, lightweight patients are at a greater risk of entrapment because their small physical dimensions may enhance their ability to fit into a gap, in whole or in part.
  • Action
    Arjohuntleigh is providing revised Instructions for Use (IFU) and additional labelling on the frame of the affected beds.

Device

Contoura 1000 and 1080 Beds (used to facilitate management of very obese patients)
  • Model / Serial
    Contoura 1000 and 1080 Beds (used to facilitate management of very obese patients)All beds manufactured since 2001ARTG Number: 205734, 206177
  • Manufacturer
    Huntleigh Healthcare Pty Ltd

Manufacturer

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