Events

Alerta De Seguridad para Guided Surgery System

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 Sales Gmbh || 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
    I1511-498
  • Número del evento
    2009DM-0003725
  • 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 it has identified that by deleting a series of merged reference data in the contentmanager, it may be a point, an object or the route, which will appear displaced or deformed in the browser for subsequent planning, leading to the occurrence of adverse events or delays in the attention of the patients.

Device

Guided Surgery System
  • Modelo / Serial
    Content Manager (Versions 2.0.0, 2.0.1, 2.0.2, 2.0.3 and 2.1.0), Patient Browser (Versions 4.0.0, 4.0.1, 4.0.2, 4.0.3 and 4.1.0) and DICOM Viewer (Versions 2.0.0, 2.0.1, 2.0.2, 2.0.3 and 2.1.0)
  • Descripción del producto
    System for guided surgery by images - modular systems for navigation that facilitate the use with software of multiple applications in surgery. Both the hardware and the software of the equipment are for exclusive use in surgeries guided by images. Use: exclusive use for surgeons.
  • Manufacturer
    Brainlab Sales Gmbh || Brainlab Ag

Manufacturer

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