Events

Retiro De Equipo (Recall) de Philips Brilliance 64 and Ingenuity CT, Core, Core128 with software version 4.1.6.XX030

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-2016-RN-01196-2
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-09-12
  • 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-01196-2
  • 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
    While performing high resolution head scans, the reconstructed images may exhibit degraded image quality manifested as:- non uniformity of the image, - ct number shift, greater than 5 hounsfield units,- reduction in grey/white matter differentiation. the issue is most severe in the high resolution mode. philips provides factory reference paediatric scan protocols which are set to high resolution by default. adult head scans have a factory reference protocol that defaults to standard resolution which does not experience the issue.
  • Acción
    Philips is advising users to perform head scan with standard resolution across all patient populations on systems running the affected software. Philips will be implementing a software correction as a permanent correction. This action has been closed-out on 15/03/2018.

Device

Philips Brilliance 64 and Ingenuity CT, Core, Core128 with software version 4.1.6.XX030
  • Modelo / Serial
    Philips Brilliance 64 and Ingenuity CT, Core, Core128 with software version 4.1.6.XX030ARTG Number: 98868
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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