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 SIEMENS 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 088 07 12 000
  • 사례 시작날짜
    2012-07-23
  • 사례 국가
    Saudi Arabia
  • 사례 출처
    SFDA
  • 사례 출처 URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=2123
  • 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 issue is isolated images of pixel depth greater than 12 bit (99% of all stored images). problem exists prior to va20d as well" analysis showed that this behaviour is caused by a software bug. in some situations it can happen that a miscalculation is done for the grey scale values in the functions "region of interest", "pixel lens", "edge enhancement" and "histograms". the min/max value of pixel density in the functions "region of interest", "pixel lens", "edge enhancement" and "histograms" is not correct for images with a pixel depth greater than 12 bit. it has to be noted that the mentioned measurements shown in prior images are also not correct. all values which are calculated for images with a pixel depth less than or equal to 12 bits are correct.

Device

Picture archiving and communication system, radiology, Syngo. Plaza and Syngo Imaging XS
  • 모델명 / 제조번호(시리얼번호)
    (1) System Label 10592 457 System version:VA20D (2) System Label104 96 279 System version:All versions VA70 and higher are affected
  • 제품 설명
    picture archiving and communication system
  • Manufacturer
    SIEMENS

Manufacturer

SIEMENS
  • 제조사 모회사 (2017)
    Siemens Ag
  • 제조사 대표
    Siemens Medical Solutions, Jeddah, (02) 6602933
  • Source
    SFDA