Events

Retiro De Equipo (Recall) de Lights - Ardon

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 Maquet SA.

¿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
    22432
  • Fecha de inicio del evento
    2018-01-12
  • País del evento
    New Zealand
  • Fuente del evento
    NZMMDSA
  • URL de la fuente del evento
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • 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: Getinge Australia Pty Ltd (NZ), 12 G Andromeda Crescent, East Tamaki, Auckland 2013
  • Causa
    The manufacturer has received complaints indicating that the central handle holder detaches easily from the cupola during use. it was determined that the cause of this malfunction is excessive tightening of the screws during mounting of the handle holder, resulting in the rivets loosening and detaching from the central handle holder ring.
  • Acción
    Product to be exchanged

Device

Lights - Ardon
  • Modelo / Serial
    Model: 5214 MAQUET VOLISTA StanOP, TRIPOD and ACCESS Cupolas Surgical lights manufactured before July 2016., Affected:
  • Manufacturer
    Maquet SA

Manufacturer

Maquet SA
  • Empresa matriz del fabricante (2017)
    Getinge AB
  • Source
    NZMMDSA