Events

Recall of Oxford Dipper 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-2017-RN-01233-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-10-18
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01233-1
  • 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 manufacturer joerns healthcare has revised the service life statement and related manufacture guidance for the oxford dipper hoist. it is possible that issues such as corrosion can occur rapidly in units older than 7 years and this may not be externally visible to users. joerns healthcare strongly recommends load testing for the oxford dipper is carried out at each and every 6 monthly inspection due to the hostile environment in which it resides and operates. the humid and corrosive nature of the pool-side locations can potentially lead to product deficiencies that may otherwise remain undetected.
  • Action
    Load testing for the Oxford Dipper should be carried out at every six-monthly inspection The Oxford Dippers that are older than 7 years need to be changed out prior to the following scheduled (6 monthly) inspection to ensure the ongoing safety of users. Recipients are requested to contact all customer(s) supplied with the supplied serial numbers, then complete the supplied Receipt Form with the appropriate box checked, according to disposition of each hoist as soon as the information becomes available or the change out is complete.

Device

Oxford Dipper Hoist
  • Model / Serial
    Oxford Dipper Hoist Models: OP10013, OP10014, X10013 and X10014Purchased between 2001 and 2010Multiple Serial Numbers affectedARTG Number: 101030
  • Manufacturer
    Sunrise Medical Pty Ltd

Manufacturer

Sunrise Medical Pty Ltd