Retiro De Equipo (Recall) de Device Recall Urethral Warmer 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 Galil Medical.

¿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
    Unit, cryosurgical, accessories - Product Code GEH
  • Causa
    This voluntary recall has been initiated because our supplier (gaymar industries, inc.) notified us that these products contain power cords that may crack or fail at or inside the plug due to a prong design problem. affected plugs can be identified by a round ground pin and black plastic bridges. cords with plugs that are not affected have u-shaped ground pins and no plastic bridges. although gali.
  • Acción
    Gaymar sent an URGENT: MEDICAL DEVICE RECALL letter dated September 30, 2010, to all consignees. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to: Customers were instructed to: " Inspect units in their possession to determine if they contain affected power cord plugs or if there were any signs of excessive wear or damage. " Immediately discontinue use and quarantine the affected product. " Contact Customer Service Department at 800-828-7341 to arrange for replacement. " Complete the attached form for each unit and follow the instructions given to return the form by fax or e-mail. " If customers further distributed the product to another person or entity, they were to identify their customers and notify them at once of this product recall by including a copy of the recall notification letter and the attached form. For questions regarding this recall call 800-828-7341 or 716-662-2551.


  • Modelo / Serial
    GW469, GW470, GW468, GW472
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    Worldwide Distribution - USA, including CA, GA, TX and the country of Canada.
  • Descripción del producto
    Urethral Warmer System Model number FPRCH3001 || The Urethral Warming System is designed to circulate a warm solution through a warming catheter to maintain urethral tissue near body temperatures while the surrounding prostate tissue is being frozen. It is intended to warm urethral tissue when performing cryogenic destruction of prostatic tissue with a Galil Medical Cryoablation System.
  • Manufacturer


  • Dirección del fabricante
    Galil Medical, 4364 Round Lake Road, Arden Hills MN 55112
  • Empresa matriz del fabricante (2017)
  • Source