Retiro De Equipo (Recall) de Device Recall Light Source, Endoscopic, Xenon Arc

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 Linvatec Corp. dba ConMed Linvatec.

¿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
    Light source, endoscope, xenon arc - Product Code GCT
  • Causa
    Linvatec corporation dba conmed linvatec, largo, fl initiated a recall of their products ls7700 xenon universal light source and ls7600 xenon light source are intended to be used with an endoscope to provide illumination during endoscopic procedures.
  • Acción
    Linvatec Corporation sent an "URGENT Medical Device Recall Notification letter dated May 20, 2011 to its customers via FedEx service. Firm advised their suppliers of the Light Sources potentially has unapproved components and does not meet the finished product requirement. The distributors and end user level are advised if any affected product is in their possession can be used until returned for advance exchange. The customers were instructed to: 1) locate the identified product by serial number at your facility and complete the Reply Form attached; 2) Contact ConMed Linvatec Customer Service (800-237-0169) to receive SR Number Advance Exchange affected product only. Once Customer Service authorizes the SR Number your Advance Exchange Light Source will be shipped to your facility; 3) Once replacement unit is received, utilize the packaging material to return the recalled Light Source to ConMed Linvatec using the enclosed FedEx Airway Bill. Mail or FAX copy of Reply Form to ConMed Linvatec; 4) Complete and return a copy of the Reply Form. For questions contact your local ConMed Linvatec office or email, Customer Service at 800-237-0169 or fax to 727-319-5701.


  • Modelo / Serial
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    Worldwide Distribution - US Nationwide and the countries of Canada, DK, HK, IN, IT, KR, MY, RU, CO, VN, ZA.
  • Descripción del producto
    ***REF LS7700***Qty 1*** EC REP*** ConMed Linvatec Xenon Universal Light Source
  • Manufacturer


  • Dirección del fabricante
    Linvatec Corp. dba ConMed Linvatec, 11311 Concept Blvd, Largo FL 33773-4908
  • Empresa matriz del fabricante (2017)
  • Source