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 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
    I1509-440
  • Número del evento
    2009EBC-0005037
  • Fecha
    2015-09-21
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=170
  • 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 the user establishes a maximum field size for each filter, this is not stipulated by the software when the fixed filters and mlc are present in the column, therefore the calculation is incorrect and the administration of the dose is out of the physical area of the filter, resulting in that the dose of distribution calculated by the software does not coincide with the dose administered, which could lead to the potential occurrence of adverse events on the patient.

Device

Elekta linear accelerator
  • Modelo / Serial
    XIO software, version 4.51 and later.
  • Descripción del producto
    Integrated system to ensure that the parameters required for a wide range of radiotherapy techniques and advanced applications are easily achieved
  • Manufacturer
    Elekta Instrument Ab

Manufacturer

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