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 Leica Microsystems Inc. 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 097 08 18 000
  • 사례 시작날짜
    2018-08-29
  • 사례 국가
    Saudi Arabia
  • 사례 출처
    SFDA
  • 사례 출처 URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=13095
  • 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
    Leica microsystems received five customer complaints stating that users inadvertently tipped over their leica m525 f20 microscope system. in four cases it was confirmed, that the issue occurred when users handled the microscope while the swing arm was in fully extended position (see figure 3 in the attached fsn). in all cases the leica m525 f20 did not cause or contribute to serious injury. the five complaints occurred in five different countries over a timeframe between the years 2010 and 2017. the leica m525 f20 was introduced in the year 2009 with more than 1000 instruments distributed globally up to date.

Device

Leica M525 F20
  • 모델명 / 제조번호(시리얼번호)
    All Leica M525 F20 Microscope Systems
  • 제품 설명
    Microscopes, Light, Operating
  • Manufacturer
    Leica Microsystems Inc.

Manufacturer

Leica Microsystems Inc.
  • 제조사 모회사 (2017)
    Danaher Corporation
  • 제조사 대표
    Al-Faisaliah Medical System
  • Source
    SFDA