Events

Stryker Neptune 2 Rover Surgical fluid/smoke waste management system 의 리콜

New Zealand Medicines and Medical Devices Safety Authority에 따르면, 해당 리콜 는 New Zealand 에서 Stryker Instruments 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
    18723
  • 사례 시작날짜
    2015-07-06
  • 사례 국가
    New Zealand
  • 사례 출처
    NZMMDSA
  • 사례 출처 URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • 비고 / 경고
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • 데이터 추가 비고
    Recalling Organisation: Stryker New Zealand Ltd, 515 Mt Wellington Highway, Mt Wellington, AUCKLAND 1060
  • 원인
    It has been identified during the installation of neptune rovers, 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 use for greater than 40 days have the potential of exhibiting the failure. neptune 2 rovers that have been used within the past 40 days are not likely to experience any issue.
  • 조치
    Product to be modified

Device

Stryker Neptune 2 Rover Surgical fluid/smoke waste management system
  • 모델명 / 제조번호(시리얼번호)
    Model: 0702-002-000, Affected: Serial Numbers ranging from 0803118093 through 1505400223
  • Manufacturer
    Stryker Instruments

Manufacturer

Stryker Instruments
  • 제조사 모회사 (2017)
    Stryker
  • Source
    NZMMDSA