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 Medical Systems 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 106 10 18 000
  • 사례 시작날짜
    2018-10-21
  • 사례 국가
    Saudi Arabia
  • 사례 출처
    SFDA
  • 사례 출처 URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=13358
  • 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
    Kv/ma lockin not functioning as specified: the lock-in function is a fluoroscopy only function. when this function is enabled, the current radiation parameters, (kv and ma values), are retained to keep a consistent image impression. this is relevant for examinations of anatomies such as knee or shoulder, where the amount of dose at the detector is strongly influenced by the amount of direct radiation. due to a software bug, the ma values are not locked, but increase when the operator restarts pulsed fluoroscopy several times after activation of the lock-in function. as a result, the patient received an increased radiation dose stitching with skyplate aborts after first image: if there is an improper synchronization between the skyplate detector and the system, the preview offset image will have artifacts. if this happens, the system software identifies the preview image buffer as not usable during the first part image acquisition of the stitching run and as a result will abort the run. the stitching run has to be repeated.

Device

CombiDiagnost,
  • 모델명 / 제조번호(시리얼번호)
    All CombiDiagnost systems with software version 1.0.0, 1.0.1 and 1.0.2
  • 제품 설명
    CombiDiagnost
  • Manufacturer
    Philips Medical Systems

Manufacturer

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