Events

Alerte De Sécurité sur Eclipse 10 (Client builds 10.0.28 and 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 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
    2011-08-29
  • 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_20110829.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
    Urgent field safety notice: eclipse 10 (client builds 10.0.28 and 10.0.34) medical device manufacturer, varian medical systems, has issued an urgent field safety notice concerning eclipse 10 (client builds 10.0.28 and 10.0.34). the issue is that the treatment field energy may change from the current selection to a previous selection without user intervention and without invalidating the mu (monitoring unit) or calculated dose distribution. the energy shown or selected by the treatment planner in the fields tab of external beam planning and in the general tab of field properties may differ from the value actually used for dose calculation. this issue is caused by incorrect handling of the energy mode object within the memory cache system used by eclipse external beam planning version 10. varian recommends the users to observe the followings: do not use multiple sessions in eclipse; always close the patient file in eclipse after completing work on the patient record; always close eclipse fully before opening a new patient. furthermore, users should compare the energy shown in dose section and lmc section (if applicable) of the “errors and warnings from last calculation” log in the calculation tab of the field properties dialog with the energy value shown in the fields tab of external beam planning to detect a discrepancy; and confirm and verify all treatment planning calculations. varian is notifying potentially affected customers and preparing a correction for eclipse version 10 to address this issue. according to the supplier, hk is not affected by this field safety notice. if you are in possession of the affected product, please contact your supplier for necessary actions.

Device

Eclipse 10 (Client builds 10.0.28 and 10.0.34)
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Eclipse 10 (Client builds 10.0.28 and 10.0.34)
  • Manufacturer
    Varian Medical Systems

Manufacturer

Varian Medical Systems