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 Philips 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 030 09 18 000
  • 사례 시작날짜
    2018-09-13
  • 사례 국가
    Saudi Arabia
  • 사례 출처
    SFDA
  • 사례 출처 URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=13138
  • 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
    Philips/ respironics everflo oxygen concentrator 1102443 has the electrical rating of 230v 60hz. however, one of the components inside the device, a compressor has a label indicating 230v 50hz, please see below figure 1. the same component also has additional label on the back side, see figure 2, this second label has the correct electrical frequencies 50/60 hz. therefore, our intent is to clarify presence of the two labels and assure of safe device performance. we would like to inform our customers that the philips everflo oxygen concentrator is fully compliant to iec 60601 and sfda.Md/iec 60601-1-1, as per sfda’s national provision article six. the shipping box (package) label and device label are provided in attachment.

Device

EverFlo (Oxygen Concentrator)
  • 모델명 / 제조번호(시리얼번호)
    model 1102443
  • 제품 설명
    Oxygen Concentrator
  • Manufacturer
    Philips

Manufacturer

Philips
  • 제조사 모회사 (2017)
    Philips
  • 제조사 대표
    Philips Healthcare Saudi Arabia Ltd.
  • Source
    SFDA