Events

Alerte De Sécurité sur Eclipse Treatment Planning System and ARIA

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
    2013-12-03
  • Date de publication de l'événement
    2013-12-09
  • 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_20131203a.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 eclipse treatment planning system and aria medical device manufacturer, varian medical systems has issued a medical device safety alert concerning eclipse treatment planning system, aria for radiation oncology, aria radiation therapy management, and acuity. the affected software versions are 11 and 13. an anomaly has been identified with the plan parameters workspace within eclipse treatment planning system, aria radiation oncology, aria radiation therapy management, and acuity. when a dose relevant parameter is changed and “do not clear monitor units and reference point dose” is selected, the monitor units may change. the monitor units of the plan may change without the user being aware when all of the following conditions are fulfilled: the plan has a primary reference point with geometrical location and the dose prescription percentage at the primary reference point is not 100% and 3d dose distribution is cleared and “do not clear monitor units and reference point doses” has been selected in the “clear 3d dose dialog” box and any dose relevant parameter is changed in the plan parameters workspace. when all these conditions are fulfilled, the dose is rescaled such that the 100% isodose is shifted to the primary reference point location. consequently, the monitor units for each treatment field will change and will not meet the dose prescription intended. for example, if the dose prescription percentage was 85% in the original plan, and a dose relevant parameter is changed, the dose prescription percentage will rescale to 100%. the monitor units will be correspondingly increased. thus, the plan will no longer meet the intended dose prescription. also, the manufacturer recommends a thorough review of treated patient plans for plans with a primary reference point with geometric location and where modifications were made in the plan parameter workspace. the manufacturer is developing a technical correction for the issue. according to the local supplier, the affected products were distributed in hong kong. if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 9 december 2013.

Device

Eclipse Treatment Planning System and ARIA
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Varian Eclipse Treatment Planning System and ARIA
  • Manufacturer
    Varian Medical Systems

Manufacturer

Varian Medical Systems