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 114 01 13 000
  • 사례 시작날짜
    2013-01-28
  • 사례 국가
    Saudi Arabia
  • 사례 출처
    SFDA
  • 사례 출처 URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=2950
  • 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 philips heartstart xl+ defibrillator/monitor may fail to power on in clinical mode and instead, power on in service mode displaying an “equipment disabled: therapy” prompt, requiring the user to enter a password and perform an operational check to clear the condition. the device will not return to clinical mode until an operational check is performed.

Device

Philips HeartStart XL+ Defibrillator/Monitor
  • 모델명 / 제조번호(시리얼번호)
    model number 861290 Units Affected: Units manufactured by Philips from October, 2011 to January 2013, and shipped worldwide with serial numbers within the ranges: USO1100100 – USO1100372 USN1100376 – USN1100960 USD1100961 – USD1101095 US11201096 – US11201186 US21201187 – US21201239 US31201240 – US31201537 US41201538 – US41201585 US51201586 – US51201721 US61201722 – US61201924 US71201925 – US71202048 US81202049 – US81202168 US91202169 – US91202514 USO1202515 – USO1202990 USN1202991 – USN1203537 USD1203538 – USD1203968 US11303969 – US11303972
  • 제품 설명
    Defibrillator/Monitor
  • Manufacturer
    Philips Healthcare

Manufacturer

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