Events

INNOVA 4100IQ - MAIN UNIT 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
    101168
  • 사례 위험등급
    III
  • 사례 시작날짜
    2012-02-07
  • 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
    Innova operator manual states that the air kerma ratio between the "low" and "normal" mode of operation during fluoroscopy exposure shall remain below 50% of normal detail mode forfluoroscopy. ge healthcare became aware of a potential issue on a specific fluoro mode setting rdl (auto-exposure preference) for which the "low" to "normal" dose rate ratio might be higher than 50% at very low dose level (6.7 mgy/min versus limit at 43.8 mgy/min) with 7.5 fps and 15 fps. as a result this issue raised a regulatory non-conformance concern. ge healthcare has completed upgrades to all affected units through software field actions thereby correcting the issue.

Device

INNOVA 4100IQ - MAIN UNIT

Manufacturer

GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)