Events

INTELEPACS 의 리콜

Health Canada (via FOI)에 따르면, 해당 리콜 는 Canada 에서 INTELERAD MEDICAL SYSTEMS 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
    139011
  • 사례 위험등급
    II
  • 사례 시작날짜
    2017-11-30
  • 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
    Following a complaint from a client intelerad is taking a pro-active field action to prevent occurrence of a possible patient safety problem at client sites. the issue is triggered by the presence of the "less than" character (<) in the report. when viewing a report the "less than" character is not present while it was there in the original report received by intelepacs. in other cases when the character is present in a combination with other characters parts of the report text following the less than character are not displayed depending on the intelerad application used by the end-user to review the reports.

Device

INTELEPACS

Manufacturer

INTELERAD MEDICAL SYSTEMS INCORPORATED