Aeroneb Pro/Solo Nebuliser Systems FRIWO power adapter 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Tag Medical Pty 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-2014-RN-01003-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2014-09-18
  • 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
    Tag medical have been advised by aerogen ltd that there is a potential hazard with certain friwo power adaptors as supplied with the aerogen pro and aerogen solo nebuliser systems manufactured during the period of week 50/2013 and week 23/2014. the power adapter could potentially fail, whereby the plastic screw pillars can break and dislodge from the body and the adapter cover can open.
  • 조치
    Tag Medical is contacting the hospitals and replacing the faulty FRIWO power adaptors free of charge. This action has been closed-out on 06/06/2016.

Device

  • 모델명 / 제조번호(시리얼번호)
    Aeroneb Pro/Solo Nebuliser Systems FRIWO power adapter Multiple catalogue numbers and date codes affectedARTG Number: 99080
  • Manufacturer

Manufacturer