Events

Retiro De Equipo (Recall) de XIMATRON

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por VARIAN MEDICAL SYSTEMS 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
    Recall
  • ID del evento
    54259
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2010-05-05
  • País del evento
    Canada
  • Fuente del evento
    HC
  • Notas / Alertas
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Notas adicionales en la data
  • Causa
    The c-series ximatron uses a lead screw drive assembly system for the focus to axis movement and for the image intensifier vertical movement. under normal use these drive systems will wear and eventually require replacement. however failure to monitor the extent of the wear of the lead screw drive assemblies could lead to a failure of the lead screw drive system. this could potentially lead to a free floating drive system that could slide on the captive gantry rails during gantry rotation when operating one or both of these drive systems potentially leading to a collision with a patient an operator the floor or the treatment table.

Device

XIMATRON
  • Modelo / Serial
    Model Catalog: CX (Lot serial: > 10 units. Contact); Model Catalog: CX (Lot serial: manufacturer.)
  • Descripción del producto
    XIMATRON
  • Manufacturer
    VARIAN MEDICAL SYSTEMS INC.

Manufacturer

VARIAN MEDICAL SYSTEMS INC.