Retiro De Equipo (Recall) de Afikim Breeze C Mobility Scooters

Según New Zealand Medicines and Medical Devices Safety Authority, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en New Zealand que fue producido por Afikim.

¿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
    15463
  • Fecha de inicio del evento
    2013-12-02
  • País del evento
  • Fuente del evento
    NZMMDSA
  • URL de la fuente del evento
  • Notas / Alertas
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Notas adicionales en la data
    Recalling Organisation: Elite Scooters (NZ) Ltd, 79 Fairview Road, Katikati, Bay Of Plenty 3129
  • Causa
    The breeze c scooter may become unresponsive during operation due to an electrical contact which may fault due to extensive wear, which potentially could result in the driver not being able to stop the scooter during operation except by turning off the ignition key.
  • Acción
    Product to be modified

Device

  • Modelo / Serial
    Model: Models: Breeze C, 3 wheel and 4 wheel scooters, Affected: Manufactured between 2-Jul-2010 and 24-Jul-2012
  • Manufacturer

Manufacturer