Events

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

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Leica Biosystems Melbourne Pty Ltd.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    RC-2016-RN-00468-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-04-18
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00468-1
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    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.
  • Action
    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...
  • Modèle / numéro de série
    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