Retiro De Equipo (Recall) de Alcon LuxOR LX3 Microscope Floor Stand(used with LuxOR LX3 and Q-VUE LX3 Ophthalmic Microscopes 175mm and 200mm)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Alcon Laboratories Australia Pty 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
  • ID del evento
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
  • País del evento
  • Fuente del evento
  • URL de la fuente del evento
  • Notas / Alertas
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • Notas adicionales en la data
  • Causa
    Alcon has observed that multiple shipments or forceful impact to a caster on a luxor lx3 microscope may stress the microscope base, which could contribute to a caster breaking or detaching from the base. during an in-facility transfer, should a caster break or detach from the base while the microscope arm is not in the most inward locked position, the unit may tip if the microscope arm is extended over the location of the broken caster. this may lead to the potential for physical injury from the microscope tipping or falling.To date, two incidents of physical injury have been reported overseas in conjunction with this issue.
  • Acción
    Alcon will contact users to schedule an appointment to inspect and retrofit LuxOR LX3 units with new bases and/or an updated caster configuration. In the interim, users are advised to ensure the articulating microscope arm is placed in a stowed and locked position over the microscope base and protect the casters from forceful impact. (Refer to recall notification for further details). Users are to contact their Alcon technical representative if they need to transport their unit to an off-site location or have immediate concerns about their unit.


  • Modelo / Serial
    Alcon LuxOR LX3 Microscope Floor Stand(used with LuxOR LX3 and Q-VUE LX3 Ophthalmic Microscopes 175mm and 200mm)Catalogue Number: 8065752560ARTG Number: 210550
  • Manufacturer