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 GE 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 087 07 13 000
  • 사례 시작날짜
    2013-07-14
  • 사례 국가
    Saudi Arabia
  • 사례 출처
    SFDA
  • 사례 출처 URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=3948
  • 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
    May exhibit various out-of-context problems. safety issue : ( description, affected products details); safety issue #1 : ( in centricity ris-ic, and a ris-driven integration, the “close” button closes the exam in ris-ic, but does not close the exam in centricity pacs ra1000 workstation, centricity pacs versions 3.2.2.3 and forward are affected ); safety issue #2 : ( interrupted workflow could break the synchronization between nuance powerscribe 360 and centricity pacs ra1000 workstation, centricity pacs versions 3.2 and forward are affected ); safety issue #3 : ( interrupted workflow could break the synchronization between agfa talk and centricity pacs ra1000 workstation, centricity pacs versions 3.1.1.2 and forward are affected ); safety issue #4 : ( centricity pacs ra1000 workstation distance measurements may not be calculated accurately when a modality sends a study to pacs which only contains values in the imager pixel spacing (0018, 1164), and magnification factor (0018, 1114) dicom tags but does not include a value in the pixel spacing (0020,0030) dicom tag, centricity pacs versions 2.X and forward).

Device

Centricity PACS RA1000 Workstations
  • 모델명 / 제조번호(시리얼번호)
    Centricity PACS versions ( 2.1.5.6; 2.1.5.8; 2.1.5.9; 2.1.5.10; 2.1.5.11; 2.1.5.13; 3.1.1.2; 3.2; 3.2.0.1; 3.2.0.2; 3.2.1; 3.2.2; 3.2.2.1; 3.2.2.2; 3.2.2.3; 3.2.6; 3.2 SP7; 4.0; 4.0.1 )
  • 제품 설명
    Workstations, Picture Archiving and Communication System
  • Manufacturer
    GE Healthcare

Manufacturer

GE Healthcare