Events

Alerta De Seguridad para Robotic Radiosurgery System CYBERKNIFE

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 ACCURAY INCORPORATED.

¿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
    I1502-64
  • Número del evento
    2009EBC-0003732
  • Fecha
    2015-02-10
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=185
  • 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 a software update should be performed for versions 8.0 that have the first generation of variable aperture collimator, since there was no linear relationship between the opening field of the collimator jaws and the size of the beam, an important relationship in the calculation of accuracy of the dose, leading to potentially serious adverse events occurring on the patient.

Device

Robotic Radiosurgery System CYBERKNIFE
  • Modelo / Serial
  • Descripción del producto
    Linear accelerator in high doses to tumors with extreme precision - offers new hope to patients all over the world. CYBERKNIFE systems are intended to provide treatment planning and guided image-guided stereotactic radiotherapy and radiotherapy for tumors, injuries and conditions anywhere in the body when radiation treatment is indicated. These systems can be used for tracheatrocytoma, glioma, tumors of the base of the skull, metastasis, (cerebral and bone), nasopharyngeal carcinoma, meningioma, acoustic neuroma, vertebral and cavernous malformations, trigeminal neuralgia and tumors of the neck and lung.
  • Manufacturer
    ACCURAY INCORPORATED

Manufacturer

ACCURAY INCORPORATED
  • Empresa matriz del fabricante (2017)
    Accuray Inc
  • Source
    NIDFSINVIMA