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
    A1609-382
  • Número del evento
    2009EBC-0005074
  • Fecha
    2016-09-09
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=122
  • 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 in a specific workflow in which the contours are modified (expanded, moved, copied, etc.) and then the contour of some cuts is deleted and saved in the same session, it is it is possible that the deleted contours are still present, even though the planner would like to eliminate them, which could lead to the potential occurrence of adverse events on the patient due to administration of incorrect doses and treatments.

Device

Elekta linear accelerator
  • Modelo / Serial
    AXESSE, SYNERGY and INFINITY, MONACO software version v3.1 and later, specific serials.
  • 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