Events

Alerte De Sécurité sur Eclipse Release 10 with ARIA™ Radiation Oncology (RT Chart module) Release 10 (Client Build 10.0.28 or Build 10.0.34)

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.

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
    2011-11-17
  • 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_20111117a.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 release 10 with aria™ radiation oncology (rt chart module) release 10 (client build 10.0.28 or build 10.0.34) medical device manufacturer, varian, has issued an urgent medical device correction concerning eclipse release 10 with aria™ radiation oncology (rt chart module) release 10 (client build 10.0.28 or build 10.0.34). an anomaly has been identified with eclipse and rt chart where adding a reference point in rt chart and editing the field dose contributions may change the prescribed dose per fraction in eclipse. according to the local supplier, the affected device has been distributed in hong kong. the issue has been corrected in a maintenance release (10mr2, client build 10.0.39) of eclipse and rt chart. varian is notifying all possibly affected customers and to schedule installation of the corrected version. if you are in possession of the affected products, please contact supplier for necessary actions.

Device

Eclipse Release 10 with ARIA™ Radiation Oncology (RT Chart module) Release 10 (Client Build 10.0....
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Varian Eclipse Release 10 with ARIAT Radiation Oncology (RT Chart module) Release 10 (Client Build 10.0.28 or Build 10.0.34)
  • Manufacturer
    Varian

Manufacturer

Varian