Events

Neptune 2 Rover Ultra (Mobile unit used as surgical fluid/smoke waste management system) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Stryker 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-2014-RN-00139-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2014-02-11
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00139-1
  • 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
    Stryker is implementing upgrades to the neptune 2 waste management system further to the previous recall for product correction in may 2013 (tga reference: rc-2013-rn-00265-1) where stryker received reports of serious injury or death in the usa due to the neptune 2 being connected to a passive chest drainage tube or closed wound drainage device post-operatively.
  • 조치
    Stryker is upgrading the Neptune 2 Rover Ultra units with a new top cap, labels and software package to mitigate the potential for incorrect use. Thia action has been closed-out on 28/01/2016.

Device

Neptune 2 Rover Ultra (Mobile unit used as surgical fluid/smoke waste management system)

Manufacturer

Stryker Australia Pty Ltd
  • 제조사 모회사 (2017)
    Stryker
  • Source
    DHTGA