Events

Harris Oxygen Flowmeter 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 HGEA 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-2015-RN-00266-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2015-04-15
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00266-1
  • 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
    Fisher & paykel healthcare pty ltd is issuing this recall for product correction on behalf of the harris products group as there have been two reports of confusion due to mislabelled measurement lines on the model 86630lox flowmeter. the measurement lines are labelled for arco2 gas and not oxygen gas. there have been no reports of injury to date, however there is potential to set up an incorrect flow of oxygen or air gas to a patient.Note: even though there have been no reports involving the air flow meter, it is being included in this recall as it also uses an arco2 labelled tube.
  • 조치
    Harris Products Group is supplying the correction labels to all affected customers. This label is to be affixed to the flow meter to correctly read the flow of Oxygen or Air gas.

Device

Harris Oxygen Flowmeter
  • 모델명 / 제조번호(시리얼번호)
    Harris Oxygen FlowmeterModel Numbers: 86630LOX and 86630LAIR (labelled as “Model 866”)All Lot Numbers ARTG No. 140296
  • Manufacturer
    HGEA Pty Ltd

Manufacturer

HGEA Pty Ltd