Events

Alerte De Sécurité sur 4D Integrated Treatment Console v8.6 with ARIA RT Chart v8.5, all of 4DITC v8.3

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
    2011-07-26
  • 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_20110726.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 v8.6 with aria rt chart v8.5, all of 4ditc v8.3 medical device manufacturer, varian, has issued an urgent field safety notice to the customers of 4ditc v8.6 with aria rt chart v8.5, all of 4ditc v8.3. the 4ditc may erratically fail to load the planned wedge without warning or notification when receiving an approved plan from the oncology information system (ois). delivery of a treatment field without the planned and calculated wedge filter could result in an over dosage for that beam and potentially an unintended dose uniformity of the target treatment volume. this errant behavior may occur with the above-affected releases of 4d integrated treatment console, v8.6 or earlier. to avoid the issue, the manufacturer recommended customers to make workflow adjustments in their planning, scheduling, and delivery portions prior to delivering a wedge field treatment. according to the local supplier, hong kong is affected. if you are in possession of the affected product, please contact your supplier for necessary actions.

Device

4D Integrated Treatment Console v8.6 with ARIA RT Chart v8.5, all of 4DITC v8.3
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: [26 Jul 2011] 4D Integrated Treatment Console v8.6 with ARIA RT Chart v8.5, all of 4DITC v8.3
  • Manufacturer
    Varian

Manufacturer

Varian