Alerte De Sécurité sur RADIOTERAPIC LINEAR ACCELERATORS CLINAC, CX, iX, UNIQUE and TRILOGY. Anvisa registry involved in this field action: 10405410017, 10405410012, 10405410010, 10405410001, 10405410011, 10405410016 and 10405410020

Selon Agência Nacional de Vigilância Sanitária (ANVISA), ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Brazil qui a été fabriqué par Varian Medical Systems Inc; Varian Medical Systems Brasil Ltda..

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
  • ID de l'événement
    1340
  • Date
    2013-12-12
  • Pays de l'événement
  • Source de l'événement
    ANVISA
  • URL de la source de l'événement
  • Notes / Alertes
    Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 Brazil.
  • Notes supplémentaires dans les données
    According to Varian Medical Systems Brazil, this problem is not related to TrueBeam devices, occurring only in Clinac®, Trilogy®, Trilogy Tx ™, Novalis Tx ™ and Unique accelerators. The company developed a technical solution that provides rules for the gantry and rotation of Clinac®, Trilogy®, Trilogy Tx ™, Novalis Tx ™ and Unique treatment tables. In physical mode, an additional screen is provided that allows the physicist to set zone limits. In clinical mode, the remote movements of the treatment table and the position of the gantry will be checked and rotation of the gantry outside the defined zone will be prohibited. Zone rules apply to the following types of movement: Remote Auto GoTo, Remote Setup, and Remote Manual Move. Actions recommended to users: • DO NOT USE GANTRY MOVEMENTS IN THE MANUAL MODE IF THE PATIENT IS FOUND IN THE TREATMENT CUP; • Observe all movement of the equipment, directly or from the outside of the treatment room, using closed circuit monitors; • When remote automatic movements are used, users should perform pre-treatment simulation inside the dome to check for potential collisions. • Always follow all warnings in the Clinac instructions for use.
  • Cause
    Occurrence of situations in which users remotely rotate the gantry by placing it in contact with the clinac treatment table.
  • Action
    Products will be field corrected by Varian.

Manufacturer