Events

Diego Elite Tubesets 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Olympus Australia 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-00397-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2015-05-12
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00397-1
  • 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
    The reason for the recall is due to a possible breach of the package’s sterile barrier, therefore compromising the sterility of the product. the breach may not be easily seen. it is important to note that there are no concerns regarding the diego elite product performance. however, as a result there has been a temporary disruption in the supply of diego elite tube sets.
  • 조치
    End users are requested to cease use of any affected product and quarantine it until it is shipped back to Olympus Australia Pty Ltd. This action has been closed-out on 08/08/2016.

Device

Diego Elite Tubesets
  • 모델명 / 제조번호(시리얼번호)
    Diego Elite TubesetsItem Codes:TS100S – Diego Elite Tubeset, StandardTS101DC – Diego Elite Tubeset, DeclogARTG Number: 143268
  • Manufacturer
    Olympus Australia Pty Ltd

Manufacturer

Olympus Australia Pty Ltd