Events

Retiro De Equipo (Recall) de Allura Xper FD20 Biplane / FD20 Biplane OR table (Flouroscopic angiographic digital x-ray system) Software versions prior to 8.1.0.3 are affected

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-2013-RN-00113-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2013-02-07
  • 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-2013-RN-00113-1
  • 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
    If using the targano wheel or speed slider to increase the image speed during the replay of a vascular biplane run, with different image sized on disk in the frontal and lateral channel (1024x1024 or 2048x2048), an image processing error will occur resulting in a system hang up.
  • Acción
    Siemens is advising the customers that until the corrective action has been implemented, the Targano wheel or speed slider should not be used to effect the image speed during replay of a vascular bi-plane run. Philips is providing a software upgrade (v 8.1.0.3) to correct the issue.

Device

Allura Xper FD20 Biplane / FD20 Biplane OR table (Flouroscopic angiographic digital x-ray system)...
  • Modelo / Serial
    Allura Xper FD20 Biplane / FD20 Biplane OR table (Flouroscopic angiographic digital x-ray system) Software versions prior to 8.1.0.3 are affectedProduct Codes: 722013 & 722025 ARTG number: 175708
  • Clasificación del producto
    Radiology Devices
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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