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 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 001 04 12 000
  • 사례 시작날짜
    2012-04-03
  • 사례 국가
    Saudi Arabia
  • 사례 출처
    SFDA
  • 사례 출처 URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=1632
  • 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 healthcare has received reports of three occurrences where the monitor ceiling suspension system fell to its lowest position. in one occasion it collided with the table top. no patient harm has been reported. the investigation initiated concluded that the cause of the failure was an assembly error of the actuator of the mcs.

Device

Radiographic/Fluoroscopic Systems
  • 모델명 / 제조번호(시리얼번호)
    System: Allura Systems FD10 , FD20, FD10/10, FD20/10 and FD20/20 (*) shipped between November 15th 2011 and March 15th 2012 that include an Actuator with an assembly error (Actuator Short Assy: 989600-184-665 and Actuator Long Assy: 989600-184-654). A limited number of Allura Sytems (3 FD10 and 1 FD20/20) (**) in which the Actuator has been replaced by an Actuator with an assembly error. (*) Productcodes: 722010, 722011, 722012, 722013, 722014, 722015, 722019, 722020, 722022, 722023, 722024, 722025 (**) Product codes: 722001, 722003 and 722008
  • 제품 설명
    Radiographic/Fluoroscopic Systems, Angiography/Interventional
  • Manufacturer
    Philips Healthcare

Manufacturer

Philips Healthcare
  • 제조사 모회사 (2017)
    Philips
  • 제조사 대표
    Al-Faisaliah Medical System, Riyadh, (01) 2119948
  • Source
    SFDA