Events

Retiro De Equipo (Recall) de Brilliance CT Big Bore with Software Versions 2.4.7 or 2.4.8 (Full body CT system)

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-2012-RN-01009-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2012-10-03
  • 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-2012-RN-01009-1
  • 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 healthcare has received a complaint stating the system opens e-stop while sitting idle causing all movements and scan to stop. the problem can occur when the scan was in "ready to scan" or scanning mode. there is a risk of undesired radiation due to the potential for a rescan if this issue happened during scanning mode.
  • Acción
    Philips Healthcare will be installing a software update to address the identified issue.

Device

Brilliance CT Big Bore with Software Versions 2.4.7 or 2.4.8 (Full body CT system)
  • Modelo / Serial
    Brilliance CT Big Bore with Software Versions 2.4.7 or 2.4.8 (Full body CT system)ARTG Number: 98868
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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