Events

Retiro De Equipo (Recall) de Post Fuse Assembly with Power Wheelchairs (electronic wheelchair)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Invacare 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-00706-3
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2012-08-13
  • 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-00706-3
  • 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
    Post fuse assemblies on certain models of power wheelchairs could potentially be defective in a manner that would result in the fuse not operating as intended (blowing) in the event of future damage or faults within the main wiring harness.
  • Acción
    Distributors to rework affected chairs with the retrofit kits provided by the Sponsor.

Device

Post Fuse Assembly with Power Wheelchairs (electronic wheelchair)
  • Modelo / Serial
    Post Fuse Assembly with Power Wheelchairs (electronic wheelchair)Multiple Model Numbers.(Distributed between 11/10/2010 and 21/10/2010)ARTG 160385
  • Manufacturer
    Invacare Australia Pty Ltd

Manufacturer

Invacare Australia Pty Ltd