Events

Retiro De Equipo (Recall) de Sorg Jump Alpha, Jump Beta and Vector WheelchairsWheelchairs with back tubes made of section tubes with groove Manufactured between 01/2008 - 09/2015

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Motum 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-2018-RN-00070-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2018-02-23
  • 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-2018-RN-00070-1
  • 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
    Motum has been made aware by the manufacturer, sorg, through continuous market observation, a potential weakness with a certain configuration of back tubes on sorg wheelchairs from the production date range of 01/2008 to 09/2015 which may result in breakage of the back tube under extreme loads. to date, there have been no injuries or harm reported as a result of this issue.
  • Acción
    Motum will be in contact with affected users to arrange for replacement of the backrest tubes.

Device

Sorg Jump Alpha, Jump Beta and Vector WheelchairsWheelchairs with back tubes made of section tube...
  • Modelo / Serial
    Sorg Jump Alpha, Jump Beta and Vector WheelchairsWheelchairs with back tubes made of section tubes with grooveManufactured between 01/2008 - 09/2015ARTG Number: 226472(Motum - Wheelchair, attendant/occupant driven)
  • Manufacturer
    Motum Pty Ltd

Manufacturer

Motum Pty Ltd