Events

Recall of Tenor without scale (Mobile patient transfer lift)

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-2014-RN-00566-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2014-05-20
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00566-1
  • 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
    During use, the bolt in the connection between the spreader bar and the lifting arm jig is subjected to mechanical forces, which may lead to breakage. this is due to the design of the connection between spreader bar and lifting arm jig, which in long term use can cause metal fatigue in this part and the formation of micro-cracks in the thread of the bolt. this issue is only related to tenor devices without scales.
  • Action
    ArjoHuntleigh will arrange for the replacement of the old spreader bar with a new spreader with scales. This action has been closed-out on 12/02/2016.

Device

Tenor without scale (Mobile patient transfer lift)

Manufacturer

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