Events

Retiro De Equipo (Recall) de Canon CXDA - 70C Wireless Computed radiographic 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 Canon Australia Pty 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-00865-3
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2012-08-27
  • 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-2012-RN-00865-3
  • 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
    It has been reported that in certain cases screws securing the electronic circuit board inside the product became loose and fell out, potentially damaging the internal electronic circuit board, resulting in malfunctions including a loss of power in some cases and possible image failures.This recall action was not notified to the tga before it was initiated by canon australia.
  • Acción
    Canon Australia is initiating a recall for product correction to replace all affected product sensor units.

Device

Canon CXDA - 70C Wireless Computed radiographic system
  • Modelo / Serial
    Canon CXDA - 70C Wireless Computed radiographic systemARTG Number: 176946
  • Manufacturer
    Canon Australia Pty Ltd

Manufacturer

Canon Australia Pty Ltd
  • Empresa matriz del fabricante (2017)
    Canon Inc
  • Source
    DHTGA