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 Radiometer Medical 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 092 11 12 000
  • 사례 시작날짜
    2012-11-21
  • 사례 국가
    Saudi Arabia
  • 사례 출처
    SFDA
  • 사례 출처 URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=2613
  • 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
    A buffer overflow may occur on the main board during a flush, which takes place when the aqt90 has been idle for more than 6 hours. the overflow could cause the analyzer to enter into an error stage with different error messages and would require a restart of the analyzer to proceed. this stage is known as the “usb software error”. in some situations the analyzer would lose current calibrations requiring a recalibration. this means that the temporary workaround described in the technical bulletin – to restart the analyzer when it has been idle for more than six hours – is no longer necessary.

Device

Blood gas analyzer, AQT90 FLEX
  • 모델명 / 제조번호(시리얼번호)
    AQT90 software version: V8.4.22
  • 제품 설명
    AQT90 FLEX, analyzer
  • Manufacturer
    Radiometer Medical

Manufacturer

Radiometer Medical
  • 제조사 모회사 (2017)
    Danaher Corporation
  • 제조사 대표
    Salehiya Trading Est., Riyadh, (01) 2628939
  • Source
    SFDA