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 012 05 11 000
  • 사례 시작날짜
    2011-05-03
  • 사례 국가
    Saudi Arabia
  • 사례 출처
    SFDA
  • 사례 출처 URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=374
  • 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
    Ge healthcare has become aware that in the event of a significant power surge, such as one that might be caused by a lightning strike or a utility equipment failure; there is a possibility that the fuse in the mru (magnet rundown unit) circuit could be affected. this situation could indirectly lead to a potential hazard if an emergency magnet quench is required.

Device

Magnetic Resonance Systems
  • 모델명 / 제조번호(시리얼번호)
    Optima MR450w, Discovery MR450, Discovery MR750, Signa HDx. Signa HDxt, Signa HFO, GE 1.5T Signa HDe, GE 1.5T Signa HDsv, Signa Excite 1.5T & 3T All MRU units (5196918) shipped to the field between October/01/2009 – December/10/2010 will be included in the fix.
  • 제품 설명
    The involved systems are whole body magnetic resonance scanners designed to support high resolution and high signal-to-noise ratio images in short exam times. They are indicated for use as a diagnostic imaging device to produce axial, sagittal, coronal, and oblique anatomical images, spectroscopic data, parametric maps, or dynamic images of the structures or functions of the entire body.
  • Manufacturer
    GE Healthcare

Manufacturer

GE Healthcare