Events

Recall of Equinox AdvantageO-Two Medical Technologies - Nitrous Oxide/Oxygen Analgesic Gas Mixing and Delivery System

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Mediquip 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-01485-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-12-18
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01485-1
  • 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, o-two medical technologies has been made aware of an incident with one of the equinox o2/n2o mixers where the oxygen supply of the reported mixer was cut off due to a disengaged piston seat in the equalizer that allowed 100% supply of nitrous oxide to be delivered to a patient.
  • Action
    Mediquip will be contacting customers directly to plan the removal and upgrade of affected units. Loan units will be provided while customer units are being upgraded. In the interim, users are advised to refer to the updated IFU provided with the Customer Letter to use the device with an oxygen analyser.

Device

Equinox AdvantageO-Two Medical Technologies - Nitrous Oxide/Oxygen Analgesic Gas Mixing and Deliv...
  • Model / Serial
    Equinox AdvantageO-Two Medical Technologies - Nitrous Oxide/Oxygen Analgesic Gas Mixing and Delivery SystemMultiple Serial NumbersARTG 225844
  • Manufacturer
    Mediquip Pty Ltd

Manufacturer

Mediquip Pty Ltd