Events

Alerta De Seguridad para Software I PLAN RT

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 Brainlab Ag.

¿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
    I1511-500
  • Número del evento
    2013EBC-0010189
  • Fecha
    2015-11-03
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=168
  • 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 if a series of non-compatible images is used in the brainlab software, it will apply the calibration of the pixel values of the image section that is in the middle of the series of cuts, causing a brightness and a different brightness to appear. the image shown by the scanner sections, leading to potential errors in treatment planning and adverse events on the patient.

Device

Software I PLAN RT
  • Modelo / Serial
  • Descripción del producto
    I PLAN ®RT: It is a system for planning irradiation treatments. It is designed for stereotaxic treatments, shaped, planned by computer and delivered with a linear accelerator. Cranial, head and neck and extracranial paralesions are used. IPLAN ® RT IMAGE: is intended for the preparation and presentation of data and images from CT, MRI, angiography, PET (to include standard uptake values, suv English, standard uptake value), as well as other types of images.
  • Manufacturer
    Brainlab Ag

Manufacturer

Brainlab Ag
  • Empresa matriz del fabricante (2017)
    Brainlab AG
  • Source
    NIDFSINVIMA