Events

Retiro De Equipo (Recall) de Device Recall SMARTABLATE RF Generator 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
    Recall
  • ID del evento
    70772
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1691-2015
  • Fecha de inicio del evento
    2015-03-19
  • Fecha de publicación del evento
    2015-05-28
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-06-17
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=134644
  • 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
    Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation - Product Code OAE
  • Causa
    Biosense webster is recalling the smartablate generator system because biosense webster has received two complaints reporting that during an rmt procedure the smartablate rf generator inadvertently delivered rf energy.
  • Acción
    Biosense Webster sent an Urgent Field Safety Notification Letter dated March 18, 2015 via FedEx to all their customers that received the affected SMARTABLATE Generator System. The letter informs the customers of the problems identified and the actions to be taken. Biosense Webster is taking precautionary safety measures of reinforcing the Warnings in the Instructions for Use (IFU) for the SMARTABLATE System Foot Pedal. Customers with questions related to the are instructed to contact their local Biosense Webster sales representative or call (866) 473-7823, Monday through Friday from 7:00AM to 8:00PM EST. Customers with questions related to the voluntary field removal certification form and its return, are instructed to contact Elie Ghattas Field Action Coordinator at (909) 839-7281.

Device

Device Recall SMARTABLATE RF Generator System
  • Modelo / Serial
    SMARTABLATE System Serial No. G4C-0296, G4C-0297, G4C-0272, G4C-0262, G4C-0232, G4C-0090.  System Serial No. G4C-0076, G4C-0195, G4C-0064, G4C-0047, G4C-0159, G4C-0187, G4C-0146, G4C-0140, G4C-0037, G4C-0131, G4C-0031, G0054.
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US Nationwide in the state of: CA, IL, KY, NJ, PA and the countries of: Czech Republic, Denmark, Finland, France, Germany, and Sweden.
  • Descripción del producto
    SMARTABLATE RF Generator System, Catalog No. M490006, M490007, M4900106, and M4900107. || Product Usage: || The use of the SMART ABLATE Generator and all accessories is indicated in combination with compatible therapeutic catheters for use in conventional intracardiac RF ablation procedures. The SMARTABLATE Foot Pedal is designed to initiate or discontinue operation of the SMARTABLATE System. The Foot Pedal can be connected to the SMARTABLATE RF Generator, SMARTABLATE Irrigation Pump; or SMARTABLATE Remote Control.
  • 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