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 146 08 13 000
  • 사례 시작날짜
    2013-08-21
  • 사례 국가
    Saudi Arabia
  • 사례 출처
    SFDA
  • 사례 출처 URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=4244
  • 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 recently become aware of a potential safety issue due to exposed yellow foam on the end bells of discovery mr450, discovery mr750, and optima mr450w products. the yellow foam strip used between the end bell covers and patient bore of certain ge mr products may extend past the surface of the covers. the foam itself is not hazardous. however, any fluid or body substance absorbed by the extended foam may come into contact with patients and act as a fomite potentially transferring infectious agents from one patient to another.

Device

Magnetic Resonance Systems, Discovery MR450, Discovery MR750, and Optima MR450w
  • 모델명 / 제조번호(시리얼번호)
    All Discovery MR450, Discovery MR750, and Optima MR450w products.
  • 제품 설명
    Magnetic Resonance Systems
  • Manufacturer
    GE Healthcare

Manufacturer

GE Healthcare