Events

Alerte De Sécurité sur RT Chart function of 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
    2011-09-08
  • 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_20110908.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: rt chart function of aria™ medical device manufacturer, varian medical systems, has issued an urgent field safety notice concerning rt chart function of aria™. according to varian, the issue is related to the use of the rt chart function in aria™, versions 8.0 and 8.1. when users select the “convert to setup field” option, a set-up field is created, that removes the dmlc (dynamic multi leaf collimator) plan components in order to create an open collimator for field light setup purposes. in a recently reported case, a user, having selected this option in error, then converted the setup field back to a treatment field. the resulting treatment field is then missing the dmlc. if this error is not detected prior to patient treatment, open field treatment can result. this issue is caused by software design limitation. varian recommends the users to perform the following actions: if you accidentally select the “convert to setup field” option, and have not pressed “save”, you can select the “reload all” button and refresh the previous data. if you accidentally select the “convert to setup field” option, and have pressed “save”, you should recreate or re-import the mlc file or treatment field in question before proceeding. follow pre-treatment plan qa program for imrt plans established in your clinic, to ensure plan validity. varian is notifying potentially affected customers and developing a service pack to modify the system behavior to prevent this accidental removal of the dmlc plan components. once available, the affected customers will be contacted by a varian service representative to schedule installation in the system. noted that, users of rt chart function aria™, version 8.2 or greater is unaffected by this fsn. according to the local supplier, hk is affected by this field safety notice and the local supplier has informed the affected parties. if you are in possession of the affected product, please contact your supplier for necessary actions.

Device

RT Chart function of ARIA
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: RT Chart function of ARIA™
  • Manufacturer
    Varian Medical Systems

Manufacturer

Varian Medical Systems