Events

Retiro De Equipo (Recall) de Ingenuity CT, Ingenuity Core, Ingenuity Core128, Brilliance 64, Brilliance iCT SP, Brilliance iCT systems with software versions 4.1.2, 4.1.3 and 4.1.4

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-2015-RN-01163-1
  • Clase de Riesgo del Evento
    Class III
  • Fecha de inicio del evento
    2015-11-27
  • 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-2015-RN-01163-1
  • 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
    On the affected ct systems and software versions, the perfusion scan feature may be unavailable. no harm has been reported, and no potential harm because of unavailability of the scanner feature.
  • Acción
    A software update will be released to correct the issue by Philips. A Philips Field Service Engineer will contact customers to schedule the software update installation at their site. This action has been closed-out on 04/07/2017.

Device

Ingenuity CT, Ingenuity Core, Ingenuity Core128, Brilliance 64, Brilliance iCT SP, Brilliance iCT...
  • Modelo / Serial
    Ingenuity CT, Ingenuity Core, Ingenuity Core128, Brilliance 64, Brilliance iCT SP, Brilliance iCT systems with software versions 4.1.2, 4.1.3 and 4.1.4 ARTG Number: 98868
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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