Events

Recall of Invacare Platinum Oxygen Concentrator

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Invacare 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-2015-RN-00383-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2015-05-07
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00383-1
  • 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
    Invacare has learned that the psi (pressure sensitive interrupter) design for the compressor motor start/run capacitor (dianz brand)could lead to rupture. that capacitor in the oxygen concentrator has an internal pressure relief component (the psi) which may not operate as intended permitting the capacitor to rupture in certain circumstances. if the psi does not function to relieve the heat and pressure due to a short circuit within the capacitor, then the pressure can cause a rupture in the seam between the housing and the end plate. if the rupture occurs, the oil may be expelled from the capacitor which may result in a fire hazard. these capacitors were utilised in production from march 2010 to august 2012 at one of our manufacturing sites.
  • Action
    Invacare is providing instruction on how to identify if an affected capacitor is present in the oxygenator. If present end users are requested to contact their distributor to arrange for a technician to replace the capacitor.

Device

Invacare Platinum Oxygen Concentrator
  • Model / Serial
    Invacare Platinum Oxygen ConcentratorModel Number : IRC9LXO2AWQ , IRC5LX02AW, IRC5LXAWARTG number: 144033
  • Manufacturer
    Invacare Australia Pty Ltd

Manufacturer

Invacare Australia Pty Ltd