Events

Alerte De Sécurité sur 4d integrated treatment console v8.6 or 8.8 in combination with treatment planning systems

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
    2012-04-18
  • 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_20120418a.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 (4ditc) v8.6 or 8.8 in combination with treatment planning systems medical device manufacturer, varian medical systems, has issued an urgent field safety notice concerning 4d integrated treatment console (4ditc) v 8.6 or 8.8 in combination with treatment planning systems. it has been identified that in certain configurations, the 4ditc can interpret a rapidarctm or vmat treatment field as 3d conformal arc treatment plan. if it happens, the field will be delivered with a constant dose rate and gantry speed for the entire duration of the delivery, which can lead to delivered dose being different from the planned dose. according to varian, this will only happen when the change in mu/deg between consecutive control points is small. in other words, it can only happen when the dose rate or gantry speed vary in a very smooth and progressive way for the entire rapidarc field. rapidarctm treatment plans created with eclipse 8.2 and higher or potentially vmat treatment plans created with 3rd party treatment planning systems, when delivered on the 4ditc v8.6 and v8.8 can be incorrectly identified as 3d conformal arc treatment plan. varian is now notifying all affected customers and will update the 4ditc software to address issues related to proper recording of treatment information from varian machines. according to the local supplier, the affected devices have been distributed in hong kong. if you are in possession of the affected product, please contact your supplier for necessary actions.

Device

4d integrated treatment console v8.6 or 8.8 in combination with treatment planning systems
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: 4D Integrated Treatment Console (4DITC) v8.6 or 8.8 in combination with treatment planning systems
  • Manufacturer
    Varian Medical Systems

Manufacturer

Varian Medical Systems