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 Encision, 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
    electrosurgical, cutting & coagulation & accessories - Product Code GEI
  • Causa
    Electrosurgical electrode tip insulation may crack and break off during use.
  • Acción
    A "Confirmation of Product Recall" letter dated April 5, 2010, was faxed by the firm (Encision, Inc.) to all customers. The letter describes the product, problem and action to be taken by customers. The customers were instructed to either return or destroy the affected electrodes and to contact any customers or sales representatives to whom they distributed the product and confirm they have been removed from use and/or they will pick them up for return. The customers is to complete form and fax to the attention of RA/QA at 1-303-444-2693 or return with the items. The number to call to arrange return and/or if you have any questions is 1-800-998-0986.


  • Modelo / Serial
    Lot No.: QAA
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    Worldwide distribution: USA including states of CA, CT, IA, IN, KS, KY, MI, OK, TX, WV, and countries of New Zealand and The Netherlands.
  • Descripción del producto
    AEM Disposable Electrode, L-Diamond, 35cm, REF ES0311, Qty 10 each Sterile R, Manufactured for: Encision Inc., Boulder, CO 80301, made in Taiwan. || Electrosurgical accessories intended, by use of monopolar high-frequency electrical current from compatible electrosurgical generators, for ablation, removal, resection and coagulation of soft tissue where associated hemostasis is required in open, endoscopic and laparoscopic surgical procedures.
  • Manufacturer


  • Dirección del fabricante
    Encision, Inc., 6797 Winchester Cir, Boulder CO 80301-3513
  • Empresa matriz del fabricante (2017)
  • Source