Events

Recall of EQUINOX ADVANTAGE NITROUS OXIDE/OXYGEN ANALGESIC GAS MIXING AND DELIVERY SYSTEM

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by O-TWO MEDICAL TECHNOLOGIES INC..

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
    150285
  • Event Risk Class
    II
  • Event Initiated Date
    2017-12-21
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Extra notes in the data
  • Reason
    The manufacturer had been made aware of an incident with one of their equinox advantage n2o/o2 anaalgesic gas mixers where the oxygen supply of the reported mixer (01eq2000 s/n#eq2016-2014) 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.

Device

EQUINOX ADVANTAGE NITROUS OXIDE/OXYGEN ANALGESIC GAS MIXING AND DELIVERY SYSTEM
  • Model / Serial
    Model Catalog: 01EQ2000-DISS (Lot serial: EQ2150-2016)
  • Product Description
    Equinox Advantage N2O/O2 Analgesic Gas Mixing and Delivery System
  • Manufacturer
    O-TWO MEDICAL TECHNOLOGIES INC.

Manufacturer

O-TWO MEDICAL TECHNOLOGIES INC.