EFILM WORKSTATION 의 리콜

Health Canada (via FOI)에 따르면, 해당 리콜 는 Canada 에서 MERGE HEALTHCARE INCORPORATED 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
    53353
  • 사례 위험등급
    III
  • 사례 시작날짜
    2014-09-19
  • 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
    On august 11 2014 a customer in another country reported that when working with multiple studies and using thumbnail panels (i.E. using a very specific workflow) the thumbnail tab changed unexpectedly. the radiologist noticed a flicker on the screen and checked the dicom study information displayed on the image. he realized that it was not the study that he had intended to add to the viewport and thus avoided dictating a report based on the wrong study. no patients were affected. upon investigation a problem was discovered where the efilm workstation software may cause the user interface for the thumbnail panel tabs to refresh and to switch tabs. if the user does not notice this it may result in the selection of a different series than the one the user intended to add (by dragging thumbnails down from the thumbnail panel) to the viewing panes in the main screen. additionally when tabs are switched selected image highlighting in the thumbnail panel may incorrectly highlight a series that does not match the series in the viewport. note that the user must look at the date on the image to confirm that the correct image series or study is being reviewed. the date information on the images is correct and is not affected by this problem.

Device

  • 모델명 / 제조번호(시리얼번호)
    Model Catalog: EFILM01 (Lot serial: N/A)
  • 제품 설명
    EFILM WORKSTATION 4.0 AND EFILM WORKSTATION 4.0.1
  • Manufacturer

Manufacturer