Events

Recall of ArjoHuntleigh Contoura 1000 & 1080 Bariatric Beds

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by ArjoHuntleigh AB.

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
    15517
  • Event Initiated Date
    2013-10-18
  • Event Country
    New Zealand
  • Event Source
    NZMMDSA
  • Event Source URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alerts
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Extra notes in the data
    Recalling Organisation: Arjo New Zealand Limited, 34 Vestey Drive, Mt Wellington, AUCKLAND 1060
  • 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
    Instructions for use to be updated

Device

ArjoHuntleigh Contoura 1000 & 1080 Bariatric Beds
  • Model / Serial
    Model: Models: 1000 & 1080, Affected: All serial numbers
  • Manufacturer
    ArjoHuntleigh AB

Manufacturer

ArjoHuntleigh AB
  • Manufacturer Parent Company (2017)
    Getinge AB
  • Source
    NZMMDSA