Events

Alerte De Sécurité sur C-Series High Energy Linear Accelerator

Selon Department of Health, ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Hong Kong qui a été fabriqué par Varian Medical Systems.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • Date
    2014-06-24
  • Date de publication de l'événement
    2014-06-24
  • Pays de l'événement
    Hong Kong
  • Source de l'événement
    DH
  • URL de la source de l'événement
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20140624a.html
  • Notes / Alertes
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Notes supplémentaires dans les données
    Medical Device Safety Alert
  • Cause
    Medical device safety alert: varian medical systems c-series high energy linear accelerator medical device manufacturer, varian medical systems, has issued a medical device safety alert concerning its c-series high energy linear accelerator, [affected models: novalis tx, trilogy, trilogy tx, clinac ix, clinac cx, clinac 2100 c/d, clinac 2300 c/d, clinac dx, clinac 21 ex, clinac 23 ex 6 mv configurations only]. the manufacturer has seen a trend in reports of unexpected decrease in beam output in c-series high energy linear accelerators for 6mv photon treatment mode. this failure mode in the target only affects the 6 mv photon treatment modes (6srs, 6fff, and 6x). no other energies are affected. the manufacturer 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 target’s deterioration and failure at an accelerated rate resulting in a rapid change in the beam output and symmetry. specifically:- the photon generation, or bremsstrahlung yield, decreases as fewer electrons are converted to photons in the target, and; 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 according to the local supplier, the affected products were distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 24 jun 2014.

Device

C-Series High Energy Linear Accelerator
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Varian Medical Systems C-Series High Energy Linear Accelerator
  • Manufacturer
    Varian Medical Systems

Manufacturer

Varian Medical Systems