Events

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

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Gascon Systems Ltd.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    RC-2018-RN-00406-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2018-05-03
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00406-1
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    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 equaliser that allowed 100% supply of nitrous oxide to be delivered to a patient.
  • Action
    Gascon 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...
  • Modèle / numéro de série
    Equinox AdvantageO-Two Medical Technologies - Nitrous Oxide/Oxygen Analgesic Gas Mixing and Delivery SystemMultiple Serial NumbersARTG Number: 222055(Gascon Systems - Analgesia unit, inhalation)
  • Manufacturer
    Gascon Systems Ltd

Manufacturer

Gascon Systems Ltd