Events

Retiro De Equipo (Recall) de SmartMonitor 2 Infant Apnea Monitor

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Respironics, Inc..

¿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
    51886
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-1411-2009
  • Fecha de inicio del evento
    2009-04-23
  • Fecha de publicación del evento
    2009-05-19
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-10-19
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=81546
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Monitor, apnea, facility use - Product Code FLS
  • Causa
    Audible alarm failure.
  • Acción
    A notification letter dated April 23, 2009 was issued to consignees informing them of the issue. Consignees were instructed to locate the affected units in their inventory and return them to Philips Children's Medical Ventures-Youngwood Service. Any units that were shipped by consignees to their customers are to be retrieved and returned to Respironics. Consignees were also instructed to complete the enclosed Business Reply Form and Serial Number Reconciliation List and fax to Stericycle at 888-345-5369 or email to respironics1985@stericycle.com. For questions and additional information about the recall, contact Stericycle Customer Service by calling at 888-345-4630.

Device

SmartMonitor 2 Infant Apnea Monitor
  • Modelo / Serial
    Model Number 4002; Serial Numbers 3000033364 through 3000038740 and Model Number 4003; Serial Numbers 3000033364 through 3000038740.
  • Clasificación del producto
    Anesthesiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide and Canada.
  • Descripción del producto
    SmartMonitor 2 Infant Apnea Monitor. || The monitor is intended for use in the continuous monitoring of respiration and heart rate of infant patients in a home or hospital environment. The monitor detects and alarms for periods of central apnea and high or low heart rates.
  • Manufacturer
    Respironics, Inc.

Manufacturer

Respironics, Inc.
  • Dirección del fabricante
    Respironics, Inc., 1001 Murry Ridge Ln, Murrysville PA 15668-8517
  • Empresa matriz del fabricante (2017)
    Philips
  • Source
    USFDA