Events

Neptune 2 Rovers(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-2015-RN-00555-1
  • 사례 위험등급
    Class III
  • 사례 시작날짜
    2015-06-30
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00555-1
  • 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
    It has been identified during the installation of neptune rovers that there is a potential for the rover’s diverter valve assembly to not actuate during docking, preventing the cleaning cycle from occurring and inhibiting prefill water from being supplied to the neptune fresh water system. the diverter valve’s material combined with the heat-treating process has the potential to cause diverter valve corrosion when the rover is allowed to sit for a period of greater than 40 days.Only neptune 2 rovers out of rotation for greater than 40 days have the potential of exhibiting the failure. there is no risk to health as the neptune rover will be unable to dock either during installation or prior to surgery. rovers that are in active rotation are not likely to experience any issue related to this diverter valve material issue.
  • 조치
    A Stryker Representative will contact affected facilities who have indicated they have Rovers which have not been used for over 40 days to schedule time to perform the diverter valve replacement. This action has been closed-out on 03/03/2016.

Device

Neptune 2 Rovers(Mobile unit used as surgical fluid/smoke waste management system)
  • 모델명 / 제조번호(시리얼번호)
    Neptune 2 Rovers(Mobile unit used as surgical fluid/smoke waste management system)Catalogue Number: 0702-001-000Serial Numbers ranging from 0803118093 through 505400223Distribution or Repair Dates: 1 Nov 2011 to 31 Mar 2015ARTG Number: 164275
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

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