Events

Retiro De Equipo (Recall) de Otto Bock A200 Power Wheelchair, SKIPPI and SKIPPI PLUS Power Wheelchairs Units delivered between 20 June 2011 and 8 March 2013

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Otto Bock 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-2014-RN-00458-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-04-23
  • 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-2014-RN-00458-1
  • 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
    During the course of on-going market observations the front caster fork complaint rate of the three wheelchairs has increased. a detailed analysis of the reports shows that the caster forks may, in unusual circumstances, break when repeatedly driven over or against street curbs.
  • Acción
    Ottobock Healthcare is replacing the caster fork on all affected A200 Power Wheelchair, SKIPPI and SKIPPI PLUS Power Wheelchairs. Product corrections are to be carried out by the wheelchair dealer. For more details, please see http://www.tga.gov.au/safety/alerts-device-ottobock-power-wheelchairs.htm .

Device

Otto Bock A200 Power Wheelchair, SKIPPI and SKIPPI PLUS Power Wheelchairs Units delivered between...
  • Modelo / Serial
    Otto Bock A200 Power Wheelchair, SKIPPI and SKIPPI PLUS Power Wheelchairs Units delivered between 20 June 2011 and 8 March 2013ARTG Number: 177246
  • Manufacturer
    Otto Bock Australia Pty Ltd

Manufacturer

Otto Bock Australia Pty Ltd