IMPAX CARDIOVASCULAR 의 리콜

Health Canada (via FOI)에 따르면, 해당 리콜 는 Canada 에서 AGFA HEALTHCARE 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
    31408
  • 사례 위험등급
    II
  • 사례 시작날짜
    2016-03-21
  • 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
    When more than one instance of outbound is running (either outbound.Bat or outbound as a windows service) report mis-attribution can occur. the symptom is: for one study patient information shows correctly on the preliminary report but shows a different patient on the final report. this situation occurs if a system is accessed via non-console rdp connections. batches or scripts placed in the startup folder (including outbound) of the corresponding domain user account are launched which can result in multiple sessions of outbound running at the same time. multiple sessions of outbound running concurrently introduces the potential for data mis-attribution.

Device

  • 모델명 / 제조번호(시리얼번호)
    Model Catalog: 7.X (Lot serial: CV 7.4); Model Catalog: 7.X (Lot serial: CV 7.8)
  • 제품 설명
    IMPAX CV REPORTING
  • Manufacturer

Manufacturer