Events

Retiro De Equipo (Recall) de Device Recall CARTO 3 Systems

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
    Recall
  • ID del evento
    61197
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1230-2012
  • Fecha de inicio del evento
    2012-02-09
  • Fecha de publicación del evento
    2012-03-20
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-09-06
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=107549
  • 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
    Some carto 3 systems may get radio frequency interference through certain interconnected cable configurations resulting in jumping or disappearing catheter icon and/or error messages during ablation.
  • Acción
    Three Urgent Customer Notification recall communications were initiated 2/9/12 with Biosense forwarding the notification to customers with affected backplane cards (electrophysiology lab managers, a notification for customers with affected back plane cards (risk managers), and a notification for customers with affected backplane cards and smarttouch module along with customer acknowledgement forms. The letters provides the customers with an explanation of the problem identified and steps to take in the event that the issue is observed. If the steps provided do not resolve the issue, customers are to contact their Biosense Webster representative. A Biosense Webster representative will contact customers to schedule an appointment for the replacement of the Backplane card. Customers were instructed to complete and return the attached Acknowledgement Form in accordance with the instructions listed on the form. If customers have questions, they can contact their BWI representative.

Device

Device Recall CARTO 3 Systems
  • Modelo / Serial
    Catalog # FG-5400-00  Serial numbers: 11996, 11998, 11999, 12002, 12026, 12031, 12040, 12046, 12047, 12051, 12052, 12057, 12061, 12062, 12063, 12065, 12066, 12067, 12069, 12070, 12075, 12077, 12078, 12086, 12087, 12088, 12089, 12094, 12096, 12098, 12099, and 12111.
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution -- US, Japan, China, Ireland, Germany, Italy, Slovenia, Indonesia, Poland, Spain, United Kingdom, Switzerland, Belgium, and Canada.
  • Descripción del producto
    CARTO 3 Systems, Product Code M-4800-01 || The intended use of the CARTO 3 System is catheter-based cardiac electrophysiological (EP) procedures.
  • Manufacturer
    Biosense Webster, Inc.

Manufacturer

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