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 137 02 18 000
  • 사례 시작날짜
    2018-02-27
  • 사례 국가
    Saudi Arabia
  • 사례 출처
    SFDA
  • 사례 출처 URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=12216
  • 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
    Upon closing the emergency stop (e-stop) the system performs an internal check. as a result of the motion controller in the couch, there is a delay in the response to the internal check. this delay may cause the couch carbon top to enter a free float state, which may allow it to move during patient load or unload activities. this free float motion results in the estop being opened due to the unexpected couch motion.

Device

Ingenuity Flex, Ingenuity CT, Ingenuity Core, Ingenuity Core128, Brilliance iCT, Brilliance iCT S...
  • 모델명 / 제조번호(시리얼번호)
    Ingenuity Flex - 728317 Ingenuity CT - 728326, 728325 Ingenuity Core - 728321 Ingenuity Core128 - 728323, 728324 Brilliance iCT - 728306 Brilliance iCT SP - 728311 Brilliance Big Bore (Oncology) - 728243 Brilliance Big Bore (Radiology) - 728244 Brilliance 16 Slice (Air) - 728246 Brilliance 16 Slice (Power) - 728240 Brilliance 40 - 728235 Brilliance 64 - 728231 IQon Spectral CT - 728332 Brilliance 6 Slice (Air) - 728256 Brilliance 10 Slice (Air) – 728251 Brilliance CT Private Practice CV config. - 728241
  • 제품 설명
    Scanning Systems, Computed Tomography
  • Manufacturer
    Philips Healthcare

Manufacturer

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