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 BrainLAB 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 050 11 11 000
  • 사례 시작날짜
    2011-11-11
  • 사례 국가
    Saudi Arabia
  • 사례 출처
    SFDA
  • 사례 출처 URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=1024
  • 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 brainscan pencil beam dose algorithm may overestimate the dose delivered to the target region if both of the following conditions are met: - the scatter measurements have been performed according to the technical reference guide (trg) “brainlab physics” (any revision), i.E. the scatter table was measured and implemented without values for equal jaw and mlc field sizes. and - in the treatment plan, the margin between jaw position and mlc field shape is set to a value smaller than the default margin of 8mm in leaf movement direction and 2mm in direction perpendicular to leaf movement.

Device

BrainSCAN ,Pencil Beam Dose Algorithm
  • 모델명 / 제조번호(시리얼번호)
    Versions 5.31 and 5.32
  • 제품 설명
    Beam Dose Algorithm
  • Manufacturer
    BrainLAB

Manufacturer

BrainLAB
  • 제조사 모회사 (2017)
    Brainlab AG
  • 제조사 대표
    Al-Faisaliah Medical System, Riyadh, (01)2119948
  • Source
    SFDA