OPTICAL GUIDANCE PLATFORM - FASTPLAN SYSTEM 의 리콜

Health Canada (via FOI)에 따르면, 해당 리콜 는 Canada 에서 VARIAN MEDICAL SYSTEMS INC. 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    19938
  • 사례 위험등급
    II
  • 사례 시작날짜
    2010-05-06
  • 사례 국가
  • 사례 출처
    HC
  • 비고 / 경고
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • 데이터 추가 비고
  • 원인
    Note: series date parameter is optional and not found on all systems. mr misalignment in cone planning could be consistently encountered on any datasets where mr data has an empty (0008 0021) series date dicom element. while the mr image could be correctly fused with a corresponding ct dataset fusion results will be incorrectly loaded into fastplan's cone planning if an empty series date data field is encountered. no warning or error message is produced. any resulting large misalignment should be obvious if the blended ct-mr view is selected since the isocenter will be misplaced on the 3d view and trace contour views. in the worst case scenario however if you use the default mr- only view settings perform planning on mr only and do not notice isocenter misplacement on the 3d view or on contour tracing slides this could lead to a significant mis-alignment of the plan.

Device

  • 모델명 / 제조번호(시리얼번호)
    Model Catalog: 9701505A (Lot serial: PCSN: HZ37010)
  • 제품 설명
    OPTICAL GUIDANCE PLATFORM - FASTPLAN SYSTEM
  • Manufacturer

Manufacturer