Events

Safety Alert for Guided Surgery System

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Brainlab Sales Gmbh || Brainlab Ag.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event ID
    I1511-498
  • Event Number
    2009DM-0003725
  • Date
    2015-11-03
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=168
  • Notes / Alerts
    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.
  • Extra notes in the data
  • Reason
    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
  • Model / 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)
  • Product Description
    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
  • Manufacturer Parent Company (2017)
    Brainlab AG
  • Source
    NIDFSINVIMA