Events

Retiro De Equipo (Recall) de CLINAC 2100C HIGH ENERGY LINEAR ACCELERATOR

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
    27100
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2012-01-12
  • 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
    A problem could occur where user may calibrate collimator angle position readout in reverse switching the 90 degree and 270 degree positions. this could cause patient treatment with the wrong collimator angle for any collimator angle other than 0 degrees iec. a reversed calibration could cause any attempt to perform a remote auto motion of the collimator to result in a failure to reach the target position. in this case the collimator would rotate in the direction opposite the proper direction to reach the target angle and would reach the mechanical limit before reaching the target angle.

Device

CLINAC 2100C HIGH ENERGY LINEAR ACCELERATOR
  • Modelo / Serial
    Model Catalog: 2100C (Lot serial: Contact manufacturer.); Model Catalog: 23EX (Lot serial: H290285); Model Catalog: TRILOGY (Lot serial: >10 Serial numbers.); Model Catalog: TRILOGY (Lot serial: Contact manufacturer.); Model Catalog: 2100C (Lot serial: >10 Serial numbers.); Model Catalog: 6EX (Lot serial: Contact manufacturer.); Model Catalog: CLINAC IX (Lot serial: >10 Serial numbers.); Model Catalog: CLINAC IX (Lot serial: Contact manufacturer.); Model Catalog: 600C (Lot serial: >10 Serial Numbers.); Model Catalog: 6EX (Lot serial: >10 Serial Numbers.); Model Catalog: NOVALIS TX (Lot serial: H294674); Model Catalog: 600C (Lot serial: Contact manufacturer.); Model Catalog: 21EX (Lot serial: Contact manufacturer.); Model Catalog: 21EX (Lot serial: >10 Serial numbers.)
  • Descripción del producto
    CLINAC 2100C HIGH ENERGY LINEAR ACCELERATOR
  • Manufacturer
    VARIAN MEDICAL SYSTEMS INC.

Manufacturer

VARIAN MEDICAL SYSTEMS INC.