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 Elekta Inc 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 013 10 12 000
  • 사례 시작날짜
    2012-10-08
  • 사례 국가
    Saudi Arabia
  • 사례 출처
    SFDA
  • 사례 출처 URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=2458
  • 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
    A patient was mistreated after a user made and saved an inadvertent change to the definition of a treatment field in mosaiq. the field edit delta display feature is designed to minimize the risk of applying inadvertent changes to the treatment field definition form. it lists and/or highlights the changes to the treatment field definition form since the last approval or delivery of the associated treatment field. the field edit delta display feature was introduced in mosaiq version 2.00n2 as a configurable risk mitigation (i.E. shipped enabled, but users with appropriate permissions could disable it). the mistreatment occurred at a site that had disabled the feature. after the mistreatment, a risk re-assessment was completed. it was concluded that the risk outweighed any benefit of allowing users to disable the feature. the feature was made non-configurable (i.E. users cannot disable it) in mosaiq version 2.41.01e5.

Device

Radiotherapy software, MOSAIQ
  • 모델명 / 제조번호(시리얼번호)
    Reference: CAR0271
  • 제품 설명
    Radiotherapy software
  • Manufacturer
    Elekta Inc

Manufacturer

Elekta Inc
  • 제조사 모회사 (2017)
    Elekta AB
  • 제조사 대표
    Analysis Device For Medical and Scientific Service ( ADMSS )
  • Source
    SFDA