Events

Retiro De Equipo (Recall) de LX3 Microscope Floor Stand

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 Alcon Research, Ltd..

¿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
    71941
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2448-2015
  • Fecha de inicio del evento
    2015-08-11
  • Fecha de publicación del evento
    2015-08-21
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-11-04
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=139415
  • 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
    Microscope, operating & accessories, ac-powered, ophthalmic - Product Code HRM
  • Causa
    Alcon is initiating a voluntary recall of all lx3 microscope floor stands after receiving reports concerning loss of functionality due to issues with the cabling between the power, host and illumination modules, potentially causing the system to display a system message, and/or resulting in illumination failure.
  • Acción
    Alcon sent an Urgent Medical Device Correction letter dated August 11, 2015 to affected customers. The letter identified the affected product, problem and actions to be taken. For questions contact Alcon at 800-862-5266.

Device

LX3 Microscope Floor Stand
  • Modelo / Serial
    All units LX3 Microscope Floor Stands manufactured prior to July 2015 (Serial Numbers 1402548501X to 1502857606X)
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US Nationwide and the countries Argentina, Australia, Austria, Belarus, Belgium, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Czech Republic, Denmark, Dominican Republic, France, Germany, Greece, Guatemala, Hungary, India, Italy, Japan, Jordan, Korea, Lebanon, Malaysia, Mexico, Mongolia, New Zealand/Fiji, Oman, Panama, Philippines, Poland, Portugal, Puerto Rico, Qatar, Romania, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Switzerland, Taiwan, Thailand, Turkey, Ukraine and United Kingdom.
  • Descripción del producto
    LX3 Floor Stand for Endure Luxite Envision Optical System; Endure LuxOR Q-Vue. || Product Usage: || The LX3 Microscope Floor Stand is an accessory to the LuxOR Opthalmic Microscope and the LuxOR Opthalmic Microscope with Q-VUE 3-D Assistant Visualization and provides a portable suspension system for the microscope that integrates an AC power module and microscope controls (Primary Control Panel and connectivity of foot controllers)
  • Manufacturer
    Alcon Research, Ltd.

Manufacturer

Alcon Research, Ltd.
  • Dirección del fabricante
    Alcon Research, Ltd., 6201 South Fwy, Fort Worth TX 76134-2099
  • Empresa matriz del fabricante (2017)
    Novartis Ag
  • Source
    USFDA