Events

Recall of Iris Hi Lo Bed(adjustable electric bed)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Pride Mobility Products Australia 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-2017-RN-00842-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-08-31
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00842-1
  • 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 tga has determined that the side rails supplied with this bed do not comply with the below listed standard and that there is a resulting risk of patient harm, including but not limited to patient entrapment:iec 60601-2-52:2009: medical electrical equipment - part 2-52: particular requirements for the basic safety and essential performance of medical beds while no safety-related incidents have been reported to date, pride australia has, as a precautionary measure have agreed to undertake a recall for product correction.
  • Action
    Pride, requests that users immediately remove the existing side rails in the event they are installed on the bed. To enable you to remove the existing side rails, Pride have supplied a leaflet of instructions demonstrating how to remove the side rails, along with the Customer Letter as an attachment. Please follow the instructions given to facilitate this recall action.

Device

Iris Hi Lo Bed(adjustable electric bed)

Manufacturer

Pride Mobility Products Australia Pty Ltd