Events

translation missing: ko.activerecord.attributes.event.titles.recall_field_safety_notice

Saudi Food & Drug Authority에 따르면, 해당 translation missing: ko.activerecord.attributes.event.types.recall_field_safety_notice 는 Saudi Arabia 에서 GE Healthcare 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

현장 안전성 서한은 의료기기 제조사 또는 제조사 대리인이 시중에 유통되고 있는 자사 의료기기 제품에 대하여 취할 수 있는 조치를 알리는 소통방식입니다. 주요 대상층은 보건의료업계 종사자와 의료기기 사용자들입니다. 여기에는 회수(recall) 조치와 경고도 포함될 수 있습니다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall / Field Safety Notice
  • 사례 ID
    mdprc 109 09 13 000
  • 사례 시작날짜
    2013-09-25
  • 사례 국가
    Saudi Arabia
  • 사례 출처
    SFDA
  • 사례 출처 URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=4420
  • 비고 / 경고
    Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug 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 Saudi Arabia.
  • 데이터 추가 비고
    Report Source: NCMDR
    SFDA urges all hospitals that have devices subjected to recall, to contact the company.
  • 원인
    Cardiacvx and cardiacvx flow report higher than actual flow values on phase-contrast images acquired with magnitude weighting mask enabled. note that this issue can only occur on phase-contrast mr protocols with the magnitude weighting mask option enabled. in the fast cine phase-contrast sequence, the magnitude weighting mask is a user configurable option (control variable or cv). in the 2d cine phase-contrast sequence (non-fast mode), magnitude weighting mask is always on, and thus would always result in this issue. the issue may result in an incorrect diagnosis if higher than actual flow values are not noticed.

Device

Imaging system software, CardiacVX and CardiacVX Flow
  • 모델명 / 제조번호(시리얼번호)
    CardiacVX (1.1.0 Ext. d) and CardiacVX Flow (1.1.0 Ext. d) analysis software running on Advantage Workstation
  • 제품 설명
    Analysis software running on Advantage Workstation.
  • Manufacturer
    GE Healthcare

Manufacturer

GE Healthcare