Events

Retiro De Equipo (Recall) de Device Recall CARTO 3 V1.05 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
    54659
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2369-2012
  • Fecha de inicio del evento
    2009-11-17
  • Fecha de publicación del evento
    2012-09-12
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-09-12
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=88917
  • 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
    The recall was initiated because biosense webster has become aware of information regarding a potential hazard that may occur during the operation of a bloom ep stimulator device in conjunction with rf generators and other electrophysiology (ep) equipment, including the carto 3 electropysiology mapping system.
  • Acción
    Biosense Webster sent an " URGENT FIELD SAFETY NOTICE" dated November 20, 2009 to all affected customers who purchased the Carto 3 Electrophysiology Mapping System. The letter informed the customers of the problem identified and the actions to be taken. Customers were instructed to continue use of the CARTO 3 System and that it was safe and no further action is needed. Customers with questions about the notice were instructed to contact Biosense Webster representatives. On January 12, 2010 another letter was sent from Biosense to all their customers recommending to avoid any connection of an EP stimulator's pacing pins to the direct ports on the CARTO 3 System when applying RF energy, unless the set up is indicated by the stimulator's instructions for use. The letter also informed the customer that the user manual for the CARTO 3 System has been formally revised to include a warning. Customers were instructed to complete an acknowledgement form to confirm receipt of the revised user manual.

Device

Device Recall CARTO 3 V1.05 System
  • Modelo / Serial
    FG-5400-00
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution-USA (nationwide) and the countries of Belgium, Canada, Denmark, France, Germany, Israel, Italy, Netherlands, and United Kingdom.
  • Descripción del producto
    CARTO 3 V1.05(FG-5400-00). || The CARTO 3 V1.05 System is intended for catheter-based atrial and ventricular mapping. The mapping system allows real-time display of cardiac maps in a number of different formats. Maps may be displayed as cardiac electrical activation maps, cardiac electrical propagation maps, cardiac electrical potential maps, impedance maps and cardiac chamber geometry maps. The acquired patient signals, including body surface ECG and intracardiac electrograms may also be displayed in real time on the System's display screen. The CARTO 3 V1.05 System is also intended to support EP procedures, maintaining CARTO¿ XP System capabilities, in the presence of a high metallic environment and provide a data communication channel to the Stereotaxis Niobe Catheter Guidance System as well as in a regular EP lab. The CARTO 3 V1.05 System includes the CartoMerge capability to import, register and merge CT or MRI structural images with CARTO Maps physiological information and real time catheter navigation, the Fast Anatomical Mapping (FAM) functionality, enabling creation of cardiac maps using'catheters with magnetic proximal and distal location sensors and the CartoSound image integration functionality, that enables integration of intracardiac echo (ICE) visualization to provide 3D combined maps. In addition to the use of specialized navigation catheters, the system is also intended for use with non-navigational electrophysiology catheters.
  • 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