Events

AW VOLUMESHARE 4 - THORACIC VCAR 의 리콜

Health Canada (via FOI)에 따르면, 해당 리콜 는 Canada 에서 GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE) 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
    91725
  • 사례 위험등급
    II
  • 사례 시작날짜
    2011-05-06
  • 사례 국가
    Canada
  • 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
    When using the summary table feature on thoracic vcar to display data incorrect patient name will be displayed if the user does not exit the application in between the analysis of two consecutive patients. if the user did not exit the application the correct imaging study will appear and the data on the summary table will contain the results of the current patient imaging study however the previous patient name will be displayed on the summary table. this summary result may be separated from the remainder of the ct imaging exam if it is printed on film or paper and incorrectly inserted in another patient's file. this issue may cause confusion and possible incorrect assessment. no adverse event has been reported related to this issue.

Device

AW VOLUMESHARE 4 - THORACIC VCAR

Manufacturer

GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)