Events

Alerta De Seguridad para Elekta linear accelerator

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 Elekta Limited || Elekta Instrument Ab.

¿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
    I1611-524
  • Número del evento
    2009EBC-0005074
  • Fecha
    2016-11-24
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=113
  • 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 has determined that when creating 3d plans using the um weight or dose modes, if the user modifies the treatment dose and / or the number of fractions of the physician's intention, and then changes the angle of the wedge, the value of um is not scaled correctly, the um scale is directly proportional to the change of the fraction, if the monitor units are not correct, in the treatment of the patient there may be an overdose or critical infrequency proportional to the redefinition of the fractions, which could lead to present potentially adverse events on the patient.

Device

Elekta linear accelerator
  • Modelo / Serial
    AXESSE, serial 152499
  • Descripción del producto
    This integrated system is designed to ensure that the parameters required for a wide range of radiotherapy techniques and advanced applications are easily achieved.
  • Manufacturer
    Elekta Limited || Elekta Instrument Ab

Manufacturer

Elekta Limited || Elekta Instrument Ab
  • Empresa matriz del fabricante (2017)
    Elekta AB
  • Source
    NIDFSINVIMA