Events

Retiro De Equipo (Recall) de ICON+ PREMO CPAP

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada 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
    23607
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2013-04-23
  • País del evento
    Canada
  • Fuente del evento
    HC
  • Notas / Alertas
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Notas adicionales en la data
  • Causa
    Fph has become aware that there is a potential power issue on certain icon cpap units. these icon cpap units could potentially become inoperable which would result in a lack of treatment to the patient's obstructive sleep apnea symptoms until a replacement unit is obtained.

Device

ICON+ PREMO CPAP
  • Modelo / Serial
    Model Catalog: ICONPBN-HT (Lot serial: 121219); Model Catalog: ICONPBN (Lot serial: 121219); Model Catalog: ICONPBN-HTC (Lot serial: 121218); Model Catalog: ICONPBN-HT (Lot serial: 121218); Model Catalog: ICONPBN (Lot serial: 121218); Model Catalog: ICONPBN-HTC (Lot serial: 121215); Model Catalog: ICONPBN-HT (Lot serial: 121215); Model Catalog: ICONPBN (Lot serial: 121215); Model Catalog: ICONPBN-HTC (Lot serial: 121213); Model Catalog: ICONPBN-HT (Lot serial: 121213); Model Catalog: ICONPBN (Lot serial: 121213); Model Catalog: ICONPBN-HTC (Lot serial: 121211); Model Catalog: ICONPBN-HT (Lot serial: 121211); Model Catalog: ICONPBN (Lot serial: 121211); Model Catalog: ICONPBN-HTC (Lot serial: 121210); Model Catalog: ICONPBN-HT (Lot serial: 121210); Model Catalog: ICONPBN (Lot serial: 121210); Model Catalog: ICONPBN-HTC (Lot serial: 121219); Model Catalog: ICONPBN (Lot serial: 121220); Model Catalog: ICONPBN-HT (Lot serial: 121220); Model Catalog: ICONPBN-HTC (Lot serial: 121220); Model Catalog: ICONPBN (Lot s
  • Descripción del producto
    ICON+ PREMO CPAP
  • Manufacturer
    FISHER AND PAYKEL HEALTHCARE LTD.

Manufacturer

FISHER AND PAYKEL HEALTHCARE LTD.