Events

Alerte De Sécurité sur Eclipse™ Treatment Planning System

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
    2012-03-20
  • 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_20120320c.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
    Field safety notice: varian eclipse™ treatment planning system medical device manufacturer, varian medical systems (varian), has issued a field safety notice concerning eclipse™ treatment planning system, versions 7.3, 8.0, 8.1, 8.2, 8.6, 8.9 and 10.0. according to varian, an anomaly has been identified with the eclipse™ treatment planning system where the calculated dose distribution is not updated or invalidated when a recalculation or reload is performed while the compensator or fluence editor is open. the issue may go unnoticed. proceeding to approve and treat with such a plan can result in the delivered dose distribution not matching the calculated dose distribution. varian is notifying all possibly affected customers with a field safety notice. according to varian, the affected devices were distributed to hong kong. if you are in possession of the products, please contact your supplier for necessary actions.

Device

Eclipse™ Treatment Planning System
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Varian FastPlan treatment planning system
  • Manufacturer
    Varian Medical Systems

Manufacturer

Varian Medical Systems