Events

Retiro De Equipo (Recall) de INFANT RADIANT WARMERS

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
    93986
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2009-10-21
  • 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
    Notifying users in canada of an updated test procedure for the power-fail alarm of the iw900 series infant radiant warmer. the service manual already includes a requirement for an annual check of the power-fail alarm. the test procedure has been revised to check that the power-fail alarm operates for at least 12 minutes. the revised test procedure accounts for any unexpected degradation over time of the supercapacitor that operates the power-fail alarm.

Device

INFANT RADIANT WARMERS
  • Modelo / Serial
    Model Catalog: IW910 (Lot serial: All Infant Warmers in Canada.); Model Catalog: IW920 (Lot serial: All Infant Warmers in Canada.); Model Catalog: IW930 (Lot serial: All Infant Warmers in Canada.); Model Catalog: IW932 (Lot serial: All Infant Warmers in Canada.); Model Catalog: IW934 (Lot serial: All Infant Warmers in Canada.); Model Catalog: IW950 (Lot serial: All Infant Warmers in Canada.); Model Catalog: IW980 (Lot serial: All Infant Warmers in Canada.); Model Catalog: ABOVE SERIES WITH SUFFIX JEU (Lot serial: All Infant Warmers in Canada.)
  • Descripción del producto
    IW900 Series Infant Warmer
  • Manufacturer
    FISHER AND PAYKEL HEALTHCARE LTD.

Manufacturer

FISHER AND PAYKEL HEALTHCARE LTD.