Events

Fujifilm Synapse CV Cardio Software 의 리콜

New Zealand Medicines and Medical Devices Safety Authority에 따르면, 해당 리콜 는 New Zealand 에서 Fujifilm Medical Systems USA 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
    16634
  • 사례 시작날짜
    2014-05-20
  • 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: Fujifilm NZ Limited, 2c William Pickering Drive, Albany, Auckland
  • 원인
    The "switch user" feature is an option in windows 7 that allows another user to open a new session with his user account without requiring the previous user to log out of the existing session. it has been discovered that running the same synapse cv client application under more than one windows user account simultaneously may cause outbound hl7 reports with incorrect data to be sent to the emr.
  • 조치
    Instructions for use to be updated

Device

Fujifilm Synapse CV Cardio Software

Manufacturer

Fujifilm Medical Systems USA Inc