Events

Retiro De Equipo (Recall) de CAPNOSTREAM 20P NX1

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 manufacturer #1479.

¿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
    20036
  • Fecha de inicio del evento
    2016-04-27
  • 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: Covidien NZ Ltd, Level 3, Building 5, Central Park Corporate Centre, 666 Great South Road, Penrose, AUCKLAND 1051
  • Causa
    Corvidien is issuing a recall for the battery pack used in oridion labeled capnostream™20p patient monitors. the scope of this recall includes battery packs that were manufactured between april 2014 and february 2016. the recall includes battery packs included with the monitors and spare replacement parts purchased separate from the monitor. this recall is due to a supplier defect in battery manufacturing that may increase the risk of thermal damage to the battery pack.
  • Acción
    Product to be destroyed

Device

CAPNOSTREAM 20P NX1

Manufacturer

manufacturer #1479