Events

Aperio eSlide Manager with ImageScope, software versions 12.2.1, 12.2.2 and 12.3. An in vitro diagnostic medical device (IVD) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Leica Biosystems Melbourne 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-2016-RN-00468-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2016-04-18
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00468-1
  • 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
    It is possible to have incorrect label information displayed when viewing multiple hamamatsu .Ndpi (brightfield) and .Ndpis (fluorescent) images with imagescope software. slides which do not use the .Ndpi file format are not affected. the correct labelling information is presented in the patient's case in eslide manager.This is an isolated issue that may only be experienced by customers who meet all of the following criteria: - use aperio eslide manager release 12.2.1 or newer including version 12.3 - use hamamatsu .Ndpi (brightfield) or .Ndpis (fluorescent) image format - open multiple images exceeding the local server cache memory no patient injury or adverse events have been reported. however, there is a potential for a delay in diagnosis, failure to diagnose or an incorrect diagnosis.
  • 조치
    Leica Biosystems is advising users to discontinue use of Hamamatsu .ndpi and ndpis image formats with ImageScope viewing software, until a software correction can be performed. Leica is recommending users review cases containing the affected image formats to ensure patient label information is correct. This action has been closed out on 14 June 2017.

Device

Aperio eSlide Manager with ImageScope, software versions 12.2.1, 12.2.2 and 12.3. An in vitro dia...
  • 모델명 / 제조번호(시리얼번호)
    Aperio eSlide Manager with ImageScope, software versions 12.2.1, 12.2.2 and 12.3. An in vitro diagnostic medical device (IVD)ARTG Number: 242392
  • Manufacturer
    Leica Biosystems Melbourne Pty Ltd

Manufacturer

Leica Biosystems Melbourne Pty Ltd