Events

Alerte De Sécurité sur 4D Integrated Treatment Console and TrueBeam

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
    2012-03-07
  • 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_20120307a.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: 4d integrated treatment console and truebeam medical device manufacturer, varian medical systems, has issued a field safety notice concerning 4d integrated treatment console (4ditc) and truebeam. varian has identified potential discrepancies in intensity modulated radiotherapy (imrt) complete irradiated area outline (ciao) outline visualization between treatment applications (4d integrated treatment console (4ditc), am editor, on-board imager, portalvision and truebeam), and treatment planning & oncology information system applications (eclipse, aria, rtchart, off-line image review). according to varian, the discrepancy is a display issue that is sometimes seen when an ad-hoc image template has been added, after the plan has been loaded on the 4ditc. none of the reported discrepancies affect the delivered dose to the imrt field, and the planned mlc and the actual mlc used for treatment are correct. p> according to the local supplier, the affected devices have been distributed in hong kong. if you are in possession of the products, please contact your supplier for necessary actions.

Device

4D Integrated Treatment Console and TrueBeam
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: 4D Integrated Treatment Console and TrueBeam
  • Manufacturer
    Varian Medical Systems

Manufacturer

Varian Medical Systems