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 052 09 15 002
  • 사례 시작날짜
    2015-12-10
  • 사례 국가
    Saudi Arabia
  • 사례 출처
    SFDA
  • 사례 출처 URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=8618
  • 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, MHRA
    SFDA urges all hospitals that have devices subjected to recall, to contact the company.
  • 원인
    Philips healthcare has discovered through customer complaints and internal testing an intermittent electronic product defect. in certain circumstances, a software error can lead to a situation where the five minute fluoroscopy audible signal does not sound, as is required in 21cfr1020.32 (h)(2)(ii) and iec 60601-2-54, clause 203.6.2.1 .C.

Device

Allura Xper FD
  • 모델명 / 제조번호(시리얼번호)
    Product codes: 722026, 722027, 722028, 722029, 722038, 722058, 722033, 722034, 722035, 722036, 722039, 722059 ........................ Swissmedic update codes : Systems: Allura Xper FD R1.2.8 Product codes: 722001, 722002, 722003 .................... MHRA update code Systems: All (upgrades to) Allura XPER or AlluraClarity with software releases 1.2.x where x<9, or 2.0.x where x<9, or 3.1.x or 4.3.x or 5.0.x or 6.0.x or 7.0.x or 7.2.x where x<8 or 7.6.x or 7.7.x or 7.8.x or 8.1.x where x< 16 or 8.2.x where x<16 All Allura Centron systems with software releases lower than 1.0.2.1 and all CV20 systems with software release 6.5.x where x<3 Product codes: 722003, 722005, 722006, 722008, 722010, 722011, 722012, 722013, 722022, 722023, 722025, 722026, 722400
  • 제품 설명
    Radiographic/Fluoroscopic Systems
  • Manufacturer
    Philips Healthcare

Manufacturer

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