Events

Recall of Invacare Platinum Oxygen Concentrators

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Invacare Rehabilitation Equipment Suzhou Co 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
    18492
  • Event Initiated Date
    2015-05-11
  • Event Country
    New Zealand
  • Event Source
    NZMMDSA
  • Event Source URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alerts
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Extra notes in the data
    Recalling Organisation: Invacare NZ Ltd, 4 Westfield Place, Mt Wellington, AUCKLAND
  • Reason
    Invacare is aware of five reported instances in the european union in which the capacitor, an internal electrical component of the concentrator, ruptured which results in a potential fire hazard. there were no injuries reported in any of the five instances.
  • Action
    Product to be modified

Device

Invacare Platinum Oxygen Concentrators

Manufacturer

Invacare Rehabilitation Equipment Suzhou Co Ltd