Events

Alerte De Sécurité sur Three-dimensional Planning System for Eclipse Radiotherapy, model eclipse versions 11; 13.0; 13.5 and 13.6, registration 10405410007, risk class III, various series.

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 Brasil Ltda.; 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
  • ID de l'événement
    1822
  • Date
    2016-02-04
  • Pays de l'événement
    Brazil
  • Source de l'événement
    ANVISA
  • URL de la source de l'événement
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • 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
    Recommendations for users and patients: DO NOT USE Eclipse versions 11, 13, 13.5 or 13.6 with the PBC 11.0.31 algorithm for conventional arc field dose calculation. #### UPDATED ON 10/25/2017, the company submitted completion report of the field action proving the accomplishment of correction as planned.
  • Cause
    An anomaly was identified with the eclipse three-dimensional planning system using pbc 11.0.31 to calculate a conventional arcuate dose distribution. when using pbc 11.0.31 to calculate the dose for a conventional arc field with more than 100 segments with eclipse versions 11.0, 13.0, 13.5 or 13.6, the displayed dose does not correspond to the monitor units ( mu) calculated. potential for unintentional radiation exposure.
  • Action
    Action code CP-23187. Varian Medical Systems Brazil has sent a Letter of Safety dated January 11, 2016 to all affected customers. The letter describes affected models, problem and necessary actions, among them the software update. For customer questions related to this help desk action of Varian Telephone: + 1-888-827-4265; E-mail: support@varian.com

Device

Three-dimensional Planning System for Eclipse Radiotherapy, model eclipse versions 11; 13.0; 13.5...

Manufacturer

Varian Medical Systems Brasil Ltda.; Varian Medical Systems.