Events

Retiro De Equipo (Recall) de ACLAIM 2 CPAP MASK

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
    97707
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2006-12-07
  • 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
    Connector component used in a previous version of its cpap masks may fail prematurely if improperly cleaned.

Device

ACLAIM 2 CPAP MASK
  • Modelo / Serial
    Model Catalog: HC401A (Lot serial: 900HC402 LOT#010918 TO 060203); Model Catalog: HC401A (Lot serial: 900HC412 LOT#020108 TO 060203); Model Catalog: HC401A (Lot serial: 900HC401X LOT#010829 TO 020517); Model Catalog: HC401A (Lot serial: HC401A LOT#020521 TO 060217); Model Catalog: HC452F (Lot serial: 900HC463 LOT#020108 TO 040604); Model Catalog: HC452A (Lot serial: 900HC463 LOT#020108 TO 040604); Model Catalog: HC451A (Lot serial: 900HC463 LOT#020108 TO 040604); Model Catalog: 900HC451T (Lot serial: 900HC463 LOT#020108 TO 040604); Model Catalog: 900HC451 (Lot serial: 900HC463 LOT#020108 TO 040604); Model Catalog: HC452F (Lot serial: 400HC209 LOT#041108 TO 050920); Model Catalog: HC452A (Lot serial: 400HC209 LOT#041108 TO 050920); Model Catalog: HC451A (Lot serial: 400HC209 LOT#041108 TO 050920); Model Catalog: 900HC451T (Lot serial: 400HC209 LOT#041108 TO 050920); Model Catalog: 900HC451 (Lot serial: 400HC209 LOT#041108 TO 050920); Model Catalog: HC452F (Lot serial: HC452F LOT#040719 TO 041102); Model Catal
  • Descripción del producto
    ACLAIM 2 CPAP MASK
  • Manufacturer
    FISHER AND PAYKEL HEALTHCARE LTD.

Manufacturer

FISHER AND PAYKEL HEALTHCARE LTD.