Events

Retiro De Equipo (Recall) de IntelliSpace Portal with AutoSPECT Pro reconstruction application (image viewing system for diagnostic imaging, x-ray and computed tomography)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Philips Electronics Australia 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-2014-RN-00364-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2014-03-26
  • 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-2014-RN-00364-1
  • 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
    During spect reconstructions using attenuation correction and scatter correction, no scatter correction is being applied in the autospect pro application on intellispace portal with the software versions mentioned above. in addition, resolution recovery is not applied correctly in spect reconstructions using astonish in autospect pro on intellispace portal unless the data is acquired with vxgp collimators. the occurrence of either problem may result in image quality degradation that could result in misdiagnosis under certain conditions.
  • Acción
    Philips is providing work around instructions to ensure the continued safe use of the AutoSPECT Pro until a software update can be provided to correct the issue. This action has been closed-out on 12/02/2016.

Device

IntelliSpace Portal with AutoSPECT Pro reconstruction application (image viewing system for diagn...
  • Modelo / Serial
    IntelliSpace Portal with AutoSPECT Pro reconstruction application (image viewing system for diagnostic imaging, x-ray and computed tomography)Affected IntelliSpace Portal software versions: v5.0.0, v5.0.1, v5.0.2 and v6.0.0ARTG Number: 188684
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

Philips Electronics Australia Ltd
  • Empresa matriz del fabricante (2017)
    Philips
  • Source
    DHTGA