Events

Retiro De Equipo (Recall) de Olympus CLV-190 Xenon Exera III Light Source

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 Olympus Medical Systems Corporation.

¿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
    17112
  • Fecha de inicio del evento
    2014-08-04
  • 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: Olympus (NZ) Ltd, 15D Paul Matthews Road, Albany, Auckland
  • Causa
    The power switch of the above mentioned models may become stuck after extended use and the following may occur:, 1) when the power switch is stuck whilst the unit is on, the unit cannot be turned off using the power switch on the model., 2) when the power switch is stuck whilst the unit is off, the unit cannot be turned on using the power switch on the unit.
  • Acción
    Product to be modified

Device

Olympus CLV-190 Xenon Exera III Light Source

Manufacturer

Olympus Medical Systems Corporation