Events

Retiro De Equipo (Recall) de Allura Xper with FlexVision large screen monitor

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-2018-RN-00830-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2018-06-25
  • 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-2018-RN-00830-1
  • 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
    Philips has received reports of instances where after a continuous operation of more than one and a half days, the image on the flexvision large screen monitor froze for about 15 seconds. thereafter, the system restored itself and was fully operational again.This is only applicable to allura systems with a flexvision large screen monitor. all other monitors to the system are not affected.To date, philips is not aware of any injuries that may have occurred due to this issue.
  • Acción
    Philips is advising this issue will be resolved in a software upgrade, expected to be available by the second half 2018. Users will be contacted by Philips when the software is available for installation. In the interim, users are advised to restart the system at least once per day to prevent occurrence of this issue.

Device

Allura Xper with FlexVision large screen monitor
  • Modelo / Serial
    Allura Xper with FlexVision large screen monitorSystem names: Allura 8.1.25.0, Allura 8.1.25.1, Allura 8.1.25.5, Allura 8.2.25.0, Allura 8.2.25.5 and Allura 8.2.27 ARTG Number: 225815(Philips Electronics Australia Ltd - X-ray system, diagnostic, fluoroscopic, angiographic, stationary, digital)
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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