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 097 10 16 000
  • 사례 시작날짜
    2016-10-13
  • 사례 국가
    Saudi Arabia
  • 사례 출처
    SFDA
  • 사례 출처 URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=10074
  • 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 thickness and location of the shielding material must be installed according to the shielding requirements provided by philips. in cases where the requirements are not followed, the distance between the passive shielding rear wall and the magnet could be insufficient. an insufficient distance leads to stronger attraction forces between the magnet and the passive shielding. these stronger forces may lead to shearing of the magnet vibration pads. in a worst case scenario, it may result in displacement of the magnet. displacement of a magnet can result in image quality issues and mechanical fitting problems with the table. these functional issues affect the clinical usage of the mr system.

Device

Achieva 3.0T and Ingenia 3.0T MR systems with passive shielding in the rear wall.
  • 모델명 / 제조번호(시리얼번호)
    MR systems have a strong magnetic field around the magnet, the so called fringe field. Reduction of this fringe field (e.g. 0.5-mT area) can be required under certain circumstances. A reduction can be achieved with ferromagnetic plates mounted to the parent walls, under the construction floor and above the RF-ceiling. These plates are called passive shielding. Passive shielding calculations require dedicated Philips Healthcare software. As documented in the Planning Reference Documentation, these calculations must be performed by Philips. It provides the requirements for the thickness and the location of the shielding material which are to be implemented, preferably by Philips’ selected RF cage suppliers.
  • 제품 설명
    MR systems
  • Manufacturer
    Philips Healthcare

Manufacturer

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