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

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Gascon Systems Ltd 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    RC-2018-RN-00406-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2018-05-03
  • 사례 국가
  • 사례 출처
    DHTGA
  • 사례 출처 URL
  • 비고 / 경고
    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.
  • 데이터 추가 비고
  • 원인
    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.
  • 조치
    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

  • 모델명 / 제조번호(시리얼번호)
    Equinox AdvantageO-Two Medical Technologies - Nitrous Oxide/Oxygen Analgesic Gas Mixing and Delivery SystemMultiple Serial NumbersARTG Number: 222055(Gascon Systems - Analgesia unit, inhalation)
  • Manufacturer

Manufacturer