Events

Recall of Volker LTC bed (with lateral release button for the side rails)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Iona Medical Products.

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-00835-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-06-30
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00835-1
  • 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 notice that a side rail of a 2080 bed lowered unintentionally and abruptly when a patient leaned over the side rail with his full body weight. hill-rom have evaluated the potential risk and determined a likelihood of occurrence less than 9/100,000 units or 0.009%.Hill-rom would like to remind users of the bed rails of 2080 beds with lateral release buttons for the side rails of the proper use of side rails. if a patient needs to exit the bed, please lower the side rails and not directly load the rail with the full patient weight.
  • Action
    Hill Rom is advising users to ensure the bed rails are lowered before bed egress or patient assisted during egress of the bed. Hill Rom will be providing a service kit to be installed by a qualified service representative in order to correct the issue.

Device

Volker LTC bed (with lateral release button for the side rails)
  • Model / Serial
    Volker LTC bed (with lateral release button for the side rails)Model Number: 2080 FSSerial Number: 2080-2007-51-46ARTG Number: 96733
  • Manufacturer
    Iona Medical Products

Manufacturer

Iona Medical Products