Retiro De Equipo (Recall) de Carto 3 EP Navigation System

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 Biosense Webster, 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
  • ID del evento
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
  • Fecha de inicio del evento
  • Fecha de publicación del evento
  • Estado del evento
  • País del evento
  • Fecha de finalización 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
    Computer, diagnostic, programmable - Product Code DQK
  • Causa
    Image disappeared from the cardiac ultrasound system when the carto 3 ep navigation system needed restarting while the patient was experiencing pericardial effusion. affects the cartosound module of the carto 3 ep navigation system when used with the soundstar eco 8f and 10f diagnostic ultrasound catheters. new precautions added.
  • Acción
    A Customer Notification Letter and Acknowledgement Form was distributed to customers on 09/10/15. One letter and form was sent via express mail, addressed to the Risk Management Office and one additional letter and form was sent by the firm's account representative to the Electrophysiology (EP/Cardiology Lab directly at the customer site. The firm's notification letter stated that they want to emphasize the following statement "The intra-cardiac ultrasound image will disappear if the CARTO 3 EP Navigation System power is disrupted and this may present a safety issue if the EP is using the ultrasound to monitor the patien during EP procedure. The ultrasound image will not reappear until the CARTO 3 System is restored." The firm will be updating the product labeling to further reinforce the precautionary statement. The firm requests that customers take the following actions: 1. Read the Field Safety Notification carefully. 2. Pass on this notification to anyone in the facility that needs to be informed of this issue, including appropriate clinical personnel involved in the use of SOUNDSTAR¿ eco Catheters. 3. Review, complete, sign and return the attached Acknowledgement Form in accordance with the instructions on the form. 4. Maintain a copy of this letter with the product. 5. Maintain awareness of the Field Safety Notification For any questions the firm states to contact the BWI sales representative.


  • Modelo / Serial
    Catalog #: C3SOUND, 10439236, 10439072, 10439011, 10438577
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    Worldwide Distribution. US nationwide, Italy, Canada, Japan, China, Singapore, Colombia, England, Russia, Spain, France, Germany, Finland, Ireland, Australia, Sweden, Hungary, India, Brazil, Slovenia, Netherlands, Mexico, and South Africa.
  • Descripción del producto
    Carto 3 EP Navigation System. Electro physiology system which views of the electrical activity of the heart through real-time data on 3-D, color-coded cardiac maps.
  • Manufacturer


  • Dirección del fabricante
    Biosense Webster, Inc., 15715 Arrow Hwy, Irwindale CA 91706-2006
  • Empresa matriz del fabricante (2017)
  • Source