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 Burton 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 016 10 17 000
  • 사례 시작날짜
    2017-10-02
  • 사례 국가
    Saudi Arabia
  • 사례 출처
    SFDA
  • 사례 출처 URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=11588
  • 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 defect involves the clock signal component within the firewall. this component has a high probability of failing in appliances that have been running for greater than 18 months. if the clock signal component were to fail, the firewall will stop functioning, will not boot, and is unable to recover from the component failure. this failure will result in a loss of communication between devices that are separated by the firewall, which may cause the information center to reboot.

Device

Philips Network, Cisco Adaptive Security Appliance (ASA) 5506 firewall
  • 모델명 / 제조번호(시리얼번호)
    Philips Network Firewall 867098 (Cisco ASA 5506 Firewall) used with the Philips IntelliVue Information Center iX or Classic Information Center. Any appliance with a serial number less than JMX2050000 are affected.
  • 제품 설명
    Adaptive Security Appliance (ASA) 5506 firewall
  • Manufacturer
    Philips Burton

Manufacturer

Philips Burton
  • 제조사 모회사 (2017)
    Philips
  • 제조사 대표
    Philips Healthcare Saudi Arabia Ltd.
  • Source
    SFDA