Events

Recall of Ceiling Bracket, Arch 71 White (used for installing Liko patient lifts to wooden and concrete ceilings)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Hill-Rom 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-01014-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-08-15
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01014-1
  • 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
    Hill-rom has received one complaint where the ceiling bracket 71 has been shipped with an increased size of the center hole.A potentially hazardous situation exists if the ceiling bracket 71 with a larger center hole is used for a concrete ceiling installation since a m8 screw and washer will be used. analysis has shown that if the bracket is mounted with a m8 screw and washer in a concrete ceiling ultra system installation (maximum load of 400 – 500 kg) there is a safety hazard associated with the installation that could potentially cause the system to fall.
  • Action
    Hill-Rom is advising the distributor to inspect stock and quarantine the affected brackets for return. All the affected stock is with the distributor. This action has been closed-out on 10/05/2017.

Device

Ceiling Bracket, Arch 71 White (used for installing Liko patient lifts to wooden and concrete cei...
  • Model / Serial
    Ceiling Bracket, Arch 71 White (used for installing Liko patient lifts to wooden and concrete ceilings)Product code: 3102071 ARTG number: 161863
  • Manufacturer
    Hill-Rom Pty Ltd

Manufacturer

Hill-Rom Pty Ltd