SYNGO.VIA 의 리콜

Health Canada (via FOI)에 따르면, 해당 리콜 는 Canada 에서 SIEMENS HEALTHCARE LIMITED 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
    78053
  • 사례 위험등급
    III
  • 사례 시작날짜
    2013-09-19
  • 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
    Siemens is providing an update package for all systems running on syngo.Via software version va20. this resolves issues encountered with the following software applications: syngo.Via ct - in workflows that contain the mm reading workflow step especially ct neuro perfusion and ct dynamic angio data may not have been loaded to the mm reading workflow step if the data set was assigned to such a workflow scanner site. - in ct bone reading the edit rib function did not work properly: after scrolling multiple times in an mpr image the marker disappeared and after editing a centerline multiple times the edited rib was not correctly displayed in the unfolded rib view. - in ct coronary analysis heart segmentation in vrt images may have been of poor quality as some parts of the heart were missing. - in ct cardiac function the identification of the annular plane did not work in pediatric studies although the system confirmed a completion of preprocessing preprocessing was not completed. syngo.Via mr - in the neuro perfusion workflow the task "remaining images" was missing. therefore it could happen that some series were not available in the workflow. syngo.Via mi - in mm oncology editing a contour could lead to an erroneous segmentation.

Device

  • 모델명 / 제조번호(시리얼번호)
    Model Catalog: 10496180 (Lot serial: LOT/SN: 100778 101414 101963)
  • 제품 설명
    SYNGO.VIA
  • Manufacturer

Manufacturer

  • 제조사 주소
    OAKVILLE
  • 제조사 모회사 (2017)
  • Source
    HC