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 Medical Systems. 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 033 01 11 000
  • 사례 시작날짜
    2011-01-17
  • 사례 국가
    Saudi Arabia
  • 사례 출처
    SFDA
  • 사례 출처 URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=5&rid=48
  • 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: http://www.sfda.gov.sa/En/MedicalEquipments/recalls/NCAR+Brief.htm
    SFDA urges all hospitals that have devices subjected to recall, to contact the company.
  • 원인
    1. when using the center on cursor feature in combination with a blended drr in certain advantagesim versions, the captured drr will remain fixed in the original position while the active drr will move to a position where the 3d cursor is centered on the screen. 2. when using the isocenter move mode feature in combination with a blended drr in certain advantagesim versions, the captured drr will remain fixed in the original position while the active drr is correctly recalculated and shown. 3. when the image series is changed (on the top left corner of a drr view) while using drr blending, the captured drr is not recalculated or cancelled. 4. when using the blended drr function the visualization of the captured drr may change without the visualization parameters (mixing and depth control) being updated on-screen after choosing a drr preset for the active drr. 5. when a new beam is created after using drr blending on a previous beam, switching back to the previous beam may cause annotations for blending, mixing and depth control to not be shown.

Device

Advantage Sim MD.
  • 모델명 / 제조번호(시리얼번호)
    Software version: 5.x, 6.x, 7.x
  • 제품 설명
    Software for X-ray system, used for radiotherapy.
  • Manufacturer
    GE Medical Systems.

Manufacturer

GE Medical Systems.