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 Beckman Coulter 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 091 04 16 000
  • 사례 시작날짜
    2016-04-24
  • 사례 국가
    Saudi Arabia
  • 사례 출처
    SFDA
  • 사례 출처 URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=9223
  • 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
    The dxh 800, dxh 600, and dxh slidemaker stainer may fail to notify the user of warnings or error conditions for low or depleted reagent conditions, daily checks failures, lis disconnection, and printer failures at: -the alert status icon(s) on the system manager -the audible alarm at the system manager -the instrument beacon on the specimen processing module or slidemaker stainer the failure may occur when the system manager application is restarted or powered off/on.

Device

DxH 800, DxH 600, and DxH Slidemaker Stainer
  • 모델명 / 제조번호(시리얼번호)
    PRODUCT : UniCel DxH 800 Coulter Cellular Analysis System REF : 629029, B24465, B24802, B68304 SOFTWARE VERSION : 2.0.0.0 and greater PRODUCT : UniCel DxH 600 Coulter Cellular Analysis System REF : B23858 SOFTWARE VERSION : 1.0.0.0 and greater PRODUCT : UniCel DxH Slidemaker Stainer Coulter Cellular Analysis System REF : 775222 SOFTWARE VERSION : 1.5.0.0 and greater
  • 제품 설명
    IVD
  • Manufacturer
    Beckman Coulter

Manufacturer

Beckman Coulter
  • 제조사 모회사 (2017)
    Danaher Corporation
  • 제조사 대표
    Al-Jeel Medical & Trading Co. LTD
  • Source
    SFDA