Events

Recall of Maxi Air Blower Unit - Model 230V (a device designed as a stretcher that is intended for use together with a patient transfer lifting for lifting a patient who is moveable only in a horizontal lying position)

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-2016-RN-00560-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-04-29
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00560-1
  • 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
    The plastic enclosure used in the maxi air supply motor for models 230v is not fire retardant. this can be seen by the "arrows" on the moulded part and was confirmed by an ad-hoc flammability test. this may increase the risk of a fire spreading.
  • Action
    An ArjoHuntleigh representative will attend the affected hospital to replace the affected blower unit.

Device

Maxi Air Blower Unit - Model 230V (a device designed as a stretcher that is intended for use toge...
  • Model / Serial
    Maxi Air Blower Unit - Model 230V (a device designed as a stretcher that is intended for use together with a patient transfer lifting for lifting a patient who is moveable only in a horizontal lying position)Serial Numbers: S0112300, S0112299, S0102544ARTG Number: 215885
  • Manufacturer
    Huntleigh Healthcare Pty Ltd

Manufacturer

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