Retiro De Equipo (Recall) de C-Series High Energy Linear Accelerator Models: Novalis Tx, Trilogy, Trilogy Tx, Clinac iX, Clinac CX, Clinac 2100 c/D, Clinac 2300C/D, Clinac DX, Clinac 21 EX, Clinac 23 EX

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Varian Medical Systems Australasia 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 I
  • 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
    Varian has seen a trend in reports of unexpected decrease in beam output in c-series high energy linacs for 6mv photon treatment mode. varian has determined the cause of the unexpected variations in beam output to be degradation of the 6mv target. specifically, the effects of modern, highly modulated treatment modes can create high levels and frequency of stress cycles in the targets particularly if the beam spot size is small. this can lead to the targets' deterioration and failure at an accelerated rate resulting in a rapid change in the beam output and symmetry. specifically:1. the photon generation, or bremsstrahlung yield, decreases as fewer electrons are converted to photons in the target, and;2. due to a resulting escape of primary electrons the output of photons, as measured by the ion chamber, might appear to be constant, but the actual photon output is decreasing.This failure mode in the target only affects the 6 mv photon treatment modes (6srs, 6fff and 6x).
  • Acción
    Varian strongly recommends that all sites implement daily output constancy checks of photon beams as recommended by the AAPM. Specifically those provided by: 1. AAPM, Task Group 142 Report: Quality Assurance of Medical Accelerators, Medical Physics publication 36 (9), September 2009, and 2. AAPM Report No. 46, Comprehensive QA for Radiation. It is particularly important that these daily output constancy checks include all 6MV beams [6SRS, 6FFF and 6X]. Sites should particularly check for any sudden decrease in dose output = 3% per day, or =6% per week. If any sudden decrease in dose output is observed, cease use of all 6MV beams and contact Varian immediately. A Varian service representative will visit the site and investigate whether the target is degrading, or has failed. A technical fix is planned for implementation in a future Clinac system control software release.


  • Modelo / Serial
    C-Series High Energy Linear Accelerator Models: Novalis Tx, Trilogy, Trilogy Tx, Clinac iX, Clinac CX, Clinac 2100 c/D, Clinac 2300C/D, Clinac DX, Clinac 21 EX, Clinac 23 EXARTG Number: 116839
  • Clasificación del producto
  • Manufacturer