Retiro De Equipo (Recall) de HeartStart MRx

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 Philips Electronics North America Corporation.

¿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
  • ID del evento
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
  • Fecha de inicio del evento
  • Estado del evento
    Open, Classified
  • País del evento
  • Fuente del evento
  • URL de la fuente del evento
  • 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
    Automated external defibrillators (non-wearable) - Product Code MKJ
  • Causa
    Mrx monitor/defibrillators could fail to charge because the therapy printed circuit board may have been loaded with an incorrect electronic component.
  • Acción
    Philips Healthcare sent an Urgent Medical Device Correction letter dated April 2016, on April 14, 2016, to all affected customers. The letter informed customers of the issue, identifies details of the units affected, gives instructions on actions to be taken by the customer and identifies what action Philips plans to take to remedy the issue. The correction will consist of providing a replacement MRx unit, free of charge, for all units affected by this issue. When the replacement unit arrives, please use the return shipping label and packaging provided with the replacement MRx unit to return the affected unit to Philips. Philips is asking customers to follow the Action to be Taken by Customer/User section of the Urgent Medical Device Correction notification/Field Safety Notice: You can continue to use your MRx prior to receiving a replacement unit. But, if you observe a red X in the Ready for Use (RFU) indicator, you should follow the troubleshooting instructions in the MRx IFU. Customers with questions were instructed to contact their local Philips representative or call 1-800-722-9377.


  • Modelo / Serial
    US00586611, US00589878, US00594232, US00588464, US00591080, US00594779, US00588657, US00592182, US00594913, US00589391, US00593861, US00595298, US00589472, US00594092, US00595443, US00589851, US00594168
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    Worldwide Distribution - US including OH, CA, NC and Internationally to China, Iraq, Japan, and Korea.
  • Descripción del producto
    HeartStart MRx Monitor/Defibrillator || The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced cardiac support, or defibrillation. It must be used by or on the order of a physician.
  • Manufacturer


  • Dirección del fabricante
    Philips Electronics North America Corporation, 3000 Minuteman Rd, Andover MA 01810-1032
  • Empresa matriz del fabricante (2017)
  • Source