Events

Recall of Sunrise Medical Sunlift Hoist

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Sunrise Medical 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-01057-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2014-11-21
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-01057-1
  • 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
    Sunrise medical is issuing a product notification following the return of 2 hoists model g175 due to the legs moving in an incorrect “v” position.Distributors and consumers are being notified of important new information relating to conditions of use and revised inspection criteria. the revised information covers conditions of use, daily checks, and ongoing maintenance requirements which will reduce possible damage to the hoist legs which in turn may affect the stability of the hoist.
  • Action
    Sunrise Medical is providing an updated user manual and advising users of the correct use of the Sunlift hoist. Sunrise Medical is requesting the customers to check the parallelism of the legs of the hoist. If the legs are toed inwards by more than 3 degrees and not parallel Sunrise is requesting the user not to use the hoist in this position. Sunrise Medical is also providing an interface bracket with fitting instructions to ensure the legs will not turn inwards. The parts will be supplied Free-of-Charge. This action has been closed-out on 18/04/2017.

Device

Sunrise Medical Sunlift Hoist
  • Model / Serial
    Sunrise Medical Sunlift Hoist Models: G150E & G175EARTG # 101030
  • Manufacturer
    Sunrise Medical Pty Ltd

Manufacturer

Sunrise Medical Pty Ltd