Retiro De Equipo (Recall) de Invacare Birdie & Flamingo Lifter, Carabineer

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 Invacare Portugal.

¿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
    13079
  • Fecha de inicio del evento
    2012-07-05
  • 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: Invacare NZ Ltd, 4 Westfield Place, Mt Wellington, AUCKLAND
  • Causa
    The carabineer used to attach the spreader bar to the lifter, may show some wear in case of intensive/ severe use. this carabineer needs to be checked and replaced if the thickness of its sections measures less than 6 mm. a change to the carabeineer's shape has also been made to reduce the potential for disengagement of the spreader bar.
  • Acción
    Product to be modified

Device

  • Modelo / Serial
    Model: Birdie, Birdie Compact, Flamingo, Affected: Serial number SN 091105631721 and higher
  • Manufacturer

Manufacturer