Events

Alerta De Seguridad para High and Low Energy Accelerators

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 Beijing Co., Ltd.

¿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
    I1407-272
  • Número del evento
    2009EBC-0004716
  • Fecha
    2014-07-07
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=201
  • 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 reports that there has been a decrease in the output of the beam for the photon treatment mode of 6mv (6srs, 6fff and 6x) due to loss of primary electrons and therefore reduction of photons in the target, leading to deficiencies of the treatments performed on patients.

Device

High and Low Energy Accelerators
  • Modelo / Serial
    CLINAC 21 EX, CLINAC 23 EX,CLINAC 2100 C/D, CLINAC 2300 C/D, CLINAC CX, CLINAC iX, CLINAC DX, NOVALIS || Tx, TRILOGY and TRILOGY Tx
  • Descripción del producto
    VARIAN model CLINAC high and low energy linear accelerators provide a conventional radiation therapy system or stereotactic radiosurgery for the management of lesions, tumors in any part of the body when radiation treatment is indicated, no diagnosis, no disease, but it provides a treatment for cancer.
  • Manufacturer
    Varian Medical Systems Beijing Co., Ltd

Manufacturer

Varian Medical Systems Beijing Co., Ltd