Events

Retiro De Equipo (Recall) de Viper & Viper Plus PowerchairsManufactured between July 2006 and July 2007

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Ausmedic 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-2013-RN-00453-1
  • Clase de Riesgo del Evento
    Class III
  • Fecha de inicio del evento
    2013-05-15
  • 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-2013-RN-00453-1
  • 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
    Instances of frame failures have been identified where considerable heavy usage of the wheelchair has instigated a fracture in the aluminium tubing that supports the rear drive motors.
  • Acción
    An upgrade kit has been supplied and fitted by a service engineer to reduce the potential for frame fracture occurring. For more details, please see http://www.tga.gov.au/safety/alerts-device-viper-wheelchairs-131003.htm .

Device

Viper & Viper Plus PowerchairsManufactured between July 2006 and July 2007
  • Modelo / Serial
    Viper & Viper Plus PowerchairsManufactured between July 2006 and July 2007This recall action was conducted prior to approval of the recall strategy by the Therapeutic Goods Administration.
  • Manufacturer
    Ausmedic Australia Pty Ltd

Manufacturer

Ausmedic Australia Pty Ltd