Events

EIZO Medical Monitors 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Arcadia Corporation Pty Ltd EIZO Oceania 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-2015-RN-00870-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2015-09-14
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00870-1
  • 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
    An internal quality control audit has revealed that image degradation (below 10bit) may occur when monitors are connected by display port on certain graphics boards. when starting up a computer or returning from sleep mode, an affected monitor displays 6-bit (64 graduations) instead of normal 8-bit (256 graduations) or 10-bit (1024 graduations).This may not be recognised by the medical images, although it can be recognised by the grey-scale images and may affected diagnostic images. monitors connected by dvi are not affected.
  • 조치
    Eizo is providing interim instructions for users to follow to identify if the users are affected by the issue. A firmware update will be provided as a permanent fix. This action has been closed-out on 18/08/2016.

Device

EIZO Medical Monitors
  • 모델명 / 제조번호(시리얼번호)
    EIZO Medical MonitorsModel Name: RX440, RX650, RX850 and GX540-CLAffected Range:RX440 - S/N 20001112 - 20931104GX540 - S/N 20001013 - 25409114, S/N 20001283 - 20210324RX650 - S/N 20001123 - 20766074RX850 - S/N 20001024 - 20133074ARTG Number: 115740
  • Manufacturer
    Arcadia Corporation Pty Ltd EIZO Oceania

Manufacturer

Arcadia Corporation Pty Ltd EIZO Oceania