Events

Volcano - Imaging Systems 의 리콜

New Zealand Medicines and Medical Devices Safety Authority에 따르면, 해당 리콜 는 New Zealand 에서 Volcano Corporation, Volcarica SRL 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
    22333
  • 사례 시작날짜
    2017-11-30
  • 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
    The microsoft windows security settings on a small number of impacted systems were incorrectly configured during the manufacturing process. this misconfiguration can lead to a windows security alert dialog being displayed when the system is switched from ivus to the ffr/ifr mode. if the user responds to the dialog by selecting 'allow access',the device's network firewall settings will be modified, opening its network ports to potential unexpected communication from the hospital network to which the device may be connected.
  • 조치
    Manufacturer to issue advice regarding use

Device

Volcano - Imaging Systems
  • 모델명 / 제조번호(시리얼번호)
    Model: , Affected: Configuration issue that affects some s5i, CORE and CORE Mobile systems with software version v3.5
  • Manufacturer
    Volcano Corporation, Volcarica SRL

Manufacturer

Volcano Corporation, Volcarica SRL
  • 제조사 모회사 (2017)
    Philips
  • Source
    NZMMDSA