Events

Retiro De Equipo (Recall) de TRILOGY 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
    113924
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2012-08-16
  • 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
    An anomaly has been found with the clinac trilogy novalis tx and unique jaw carriers. the jaw carriers function to couple the x-jaws to their respective drive screw mechanisms used for controlling field size. some jaw carriers were manufactured with the incorrect metal alloy which can potentialy cause the jaw carrier to crack. if both jaw carriers on the same x-jaw were to crack the jaw would be able to move freely in the closed direction. in this case the deviation of the jaw position will not be detected by the position readout interlock circuitry. treatment after such a failure occurs may lead to an under -dose of the intended target volume.

Device

TRILOGY HIGH ENERGY LINEAR ACCELERATOR
  • Modelo / Serial
    Model Catalog: TRILOGY (Lot serial: H294674); Model Catalog: CLINAC IX (Lot serial: H294758); Model Catalog: CLINAC IX (Lot serial: H294684); Model Catalog: NOVALIS TX (Lot serial: H294751); Model Catalog: CLINAC IX (Lot serial: H294766); Model Catalog: CLINAC IX (Lot serial: H294683); Model Catalog: CLINAC IX (Lot serial: H294750); Model Catalog: CLINAC IX (Lot serial: H294675)
  • Descripción del producto
    Trilogy High Energy Linear Accelerator
  • Manufacturer
    VARIAN MEDICAL SYSTEMS INC.

Manufacturer

VARIAN MEDICAL SYSTEMS INC.