Events

Volcano s5/s5i/CORE/CORE Mobile Systems with FFR option 의 리콜

New Zealand Medicines and Medical Devices Safety Authority에 따르면, 해당 리콜 는 New Zealand 에서 Volcano Corp 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
    19005
  • 사례 시작날짜
    2015-09-15
  • 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: Device Technologies New Zealand, 47 Arrenway Drive, Albany, AUCKLAND 0632
  • 원인
    Volcano corp. has discovered a very specific workflow scenario where the aortic pressure (pa) offset used in the ffr/ifr modalities will be lost or reset to 0 mmhg due to a software error. this issue can lead to an inaccurately calculated ffr or ifr value. should this occur, a clinician may rely on an inaccurate value in diagnosing a patient's condition.
  • 조치
    Software to be upgraded

Device

Volcano s5/s5i/CORE/CORE Mobile Systems with FFR option
  • 모델명 / 제조번호(시리얼번호)
    Model: Volcano s5 and CORE series, Affected: Software versions 3.3, 3.4 (with and without iFR Scout technology) and v3.4 software kits
  • Manufacturer
    Volcano Corp

Manufacturer

Volcano Corp
  • 제조사 모회사 (2017)
    Philips
  • Source
    NZMMDSA