Events

Rappel 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

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Varian Medical Systems Australasia Pty Ltd.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    RC-2014-RN-00700-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2014-07-02
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00700-1
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    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).
  • Action
    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.

Device

C-Series High Energy Linear Accelerator Models: Novalis Tx, Trilogy, Trilogy Tx, Clinac iX, Clina...
  • Modèle / numéro de série
    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
  • Classification du dispositif
    Radiology Devices
  • Manufacturer
    Varian Medical Systems Australasia Pty Ltd

Manufacturer

Varian Medical Systems Australasia Pty Ltd