Events

Retiro De Equipo (Recall) de Fisher & Paykel RT008 Air Entrainer

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 Fisher and Paykel Healthcare 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
    15355
  • Fecha de inicio del evento
    2013-09-13
  • 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: Fisher and Paykel Healthcare Ltd, 15 Maurice Paykel Place, East Tamaki, AUCKLAND 2013
  • Causa
    Fisher & paykel healthcare (fph) has become aware that the rt008 entrainers with lot number 130726 may potentially be difficult to rotate. our risk evaluation identified no safety risk for this issue. however, it can potentially cause user inconvenience and a replacement may be required.
  • Acción
    Product to be exchanged

Device

Fisher & Paykel RT008 Air Entrainer

Manufacturer

Fisher and Paykel Healthcare Ltd