Events

INNOVA 2121IQ (Cardiovascular X-ray imaging system) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 GE Healthcare Australia Pty Ltd 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
    RC-2014-RN-00210-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2014-03-03
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00210-1
  • 비고 / 경고
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • 데이터 추가 비고
  • 원인
    The innova system may not boot up properly after a power-on or after a system reset. additionally it may shut down unexpectedly during an exam which may result in the total loss of real-time interventional imaging. the loss of the fluoro imaging capability may cause substantial harm to a patient, in case it happens during a "sensitive phase" of a coronary intervention.
  • 조치
    GE Healthcare is advising users to ensure a quick functional check is performed before use. GE will be correcting all affected systems.

Device

INNOVA 2121IQ (Cardiovascular X-ray imaging system)
  • 모델명 / 제조번호(시리얼번호)
    INNOVA 2121IQ (Cardiovascular X-ray imaging system)Serial Number 589404BU3ARTG Number: 93871
  • Manufacturer
    GE Healthcare Australia Pty Ltd

Manufacturer

GE Healthcare Australia Pty Ltd