Events

Welch Allyn Propaq LT/ Propaq 802 Patient Monitor 의 리콜

New Zealand Medicines and Medical Devices Safety Authority에 따르면, 해당 리콜 는 New Zealand 에서 Welch Allyn Protocol Inc 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
    15629
  • 사례 시작날짜
    2013-11-15
  • 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: Medxus Ltd, Unit 4, 100 Fitgerald Avenue, Christchurch 8011
  • 원인
    Internal serial testing has identified fault conditions relating to hardware or software failure or electrical noise caused by proximal defibrillation activity that could, in rare instances, potentially interrupt propaq lt device operations. if this were to occur the device would either present an error screen instructing the user to restart the monitor, or could present a blank screen or white screen.Either screen would be accompanied by one or more blimking led lights, and in either case, the isue would be resolved by restarting (power cycling) the monitor.
  • 조치
    Software to be upgraded

Device

Welch Allyn Propaq LT/ Propaq 802 Patient Monitor
  • 모델명 / 제조번호(시리얼번호)
    Model: 802LTAN, 802LTON, 802LTRN, Affected:
  • Manufacturer
    Welch Allyn Protocol Inc

Manufacturer

Welch Allyn Protocol Inc