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
    45281
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2009-10-15
  • 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 updating cleaning instructions for the iw900 series infant radiant warmers. the inclusion of the recommended and non-recommended proprietary cleaning products supplements the current operating instructions and technical manual held by canadian customers which already cautions against using solutions containing specifically named chemicals.

Device

INFANT RADIANT WARMERS
  • Modelo / Serial
    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: WITH SUFFIX JEU (Lot serial: All Infant Warmers in Canada.); Model Catalog: IW920 (Lot serial: All Infant Warmers in Canada.); Model Catalog: IW910 (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.