Events

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

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Leica Biosystems Melbourne Pty Ltd.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    RC-2016-RN-00468-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-04-18
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00468-1
  • Notas / Alertas
    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.
  • Notas adicionales en la data
  • Causa
    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.
  • Acción
    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...
  • Modelo / 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