Events

Recall of Aidacare FL250 Bed, Single and King Single

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Aidacare 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-2018-RN-00840-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2018-07-02
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00840-1
  • 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
    Aidacare has identified a labelling error pertaining to electrical classification on the manufacturer id sticker – it is shown as class ii device when the device is class i. this mislabelling creates the potential for testing and tagging to be incorrectly administered on fl250 beds.The class is labelled correctly on the control unit under the bed.
  • Action
    Aidacare is advising that they will contact impacted customers to arrange for on-site correction.

Device

Aidacare FL250 Bed, Single and King Single
  • Model / Serial
    Aidacare FL250 Bed, Single and King SingleProduct Codes: BEB046100 (Single) and BEB046150 (King Single)Dates of Manufacture – 22 June 2017 to 17 May 2018ARTG Number: 287924(Aidacare Pty Ltd - Bed, disabled person, electrical)
  • Manufacturer
    Aidacare Pty Ltd

Manufacturer

Aidacare Pty Ltd