Events

Alerta De Seguridad para Treatment planning system

Según National Institute of Drugs and Food Surveillance (INVIMA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Colombia que fue producido por Varian Medical Systems Imaging Laboratory Gmbh || Varian Medical Systems, Inc.

¿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
    I1602-54
  • Número del evento
    2009EBC-0004720
  • Fecha
    2016-02-11
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=157
  • Notas / Alertas
    Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 recall data from the U.S. and Colombia.
  • Notas adicionales en la data
  • Causa
    The manufacturer states that it has identified anomalies in the field dose calculation of conventional arc therapy (arcotherapy), leading to the possible occurrence of adverse events or delays in patient care.

Device

Treatment planning system
  • Modelo / Serial
    Software versions 11, 13.0, 13.5 and 13.6, with Pencil Beam Convolution algorithm 11.0.31.
  • Descripción del producto
    Indicated in radiotherapy in applications for cancer treatment. Used in external or internal beam planning of radiation treatments for patients with known physiological conditions to cope with the radiation of therapeutic photons beams, electron beam, proton beams or radioisotopes.
  • Manufacturer
    Varian Medical Systems Imaging Laboratory Gmbh || Varian Medical Systems, Inc

Manufacturer

Varian Medical Systems Imaging Laboratory Gmbh || Varian Medical Systems, Inc