Events

Alerta De Seguridad para 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.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Varian Medical Systems Brasil Ltda.; Varian Medical Systems..

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • ID del evento
    1822
  • Fecha
    2016-02-04
  • País del evento
    Brazil
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    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.
  • Causa
    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.
  • Acción
    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.