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 Gamma Cameras 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 086 08 17 000
  • 사례 시작날짜
    2017-08-24
  • 사례 국가
    Saudi Arabia
  • 사례 출처
    SFDA
  • 사례 출처 URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=11452
  • 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
    In order to save archiving space, the allura xper r9 systems and azurion r1.1 systems include the option of downscaling the image when exporting images to the external dicom destination (e.G., pacs). when using the downscale option, the measurements performed with the allura r9 system or azurion r1.1 system using the qa basic measurement tool will not be correctly exported to the external dicom destination. the difference between the original measurement and the exported measurement can vary. the distance value after export is factor 1 to 4 smaller than the original value. the difference will depend on the acquired image (e.G., x-ray protocol, field of view) and the used archive settings (i.E., downscale settings).

Device

Allura Xper R9 and Azurion R1.1
  • 모델명 / 제조번호(시리얼번호)
    Allura Xper R9 and Azurion R1.1 systems with the QA Basic Measurement tool. Product names: Allura Xper R9 7M12, Allura Xper R9 7M20, Azurion 7M12; Azurion 7M20; Azurion 3M12; Azurion 3M15
  • 제품 설명
    imaging systems
  • Manufacturer
    Philips Healthcare Gamma Cameras

Manufacturer

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