Events

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

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Leica Biosystems Melbourne Pty Ltd.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    RC-2016-RN-00468-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-04-18
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00468-1
  • Notes / Alerts
    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.
  • Extra notes in the data
  • Reason
    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...
  • Model / Serial
    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