Retiro De Equipo (Recall) de Oxford Advance only manufactured prior to July, 2010 (Prior to serial number 1007L0001)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Sunrise Medical 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
  • ID del evento
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
  • País del evento
  • Fuente del evento
  • URL de la fuente del evento
  • 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
    Two reported incidences have occurred since the product was first released in december 2004, where the upper base casting has fractured. the looseness or removal of the four screws that locate the base plate to the upper base casting may allow the base casting to be distorted or weakened under load and possibly fracture if excessive force is applied.This recall action undertaken in february 2013 was carried out prior to the approval of the recall strategy by the tga.
  • Acción
    Sunrise Medical is advising users that affected units will be upgraded as part of the next scheduled inspection. This action has bee closed-out on 12/02/2016.


  • Modelo / Serial
    Oxford Advance only manufactured prior to July, 2010 (Prior to serial number 1007L0001)ARTG Number: 101303
  • Manufacturer