Events

Safety Alert for Planning System for Radiosurgery - Software

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by 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
    I1501-6
  • Event Number
    2013DM-0010003
  • Date
    2015-01-02
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=190
  • 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 under specific conditions the patient's position in the linear accelerator may be incorrect when using the referenced software, leading to possible adverse events being presented to patients.

Device

Planning System for Radiosurgery - Software
  • Model / Serial
    iPlan RT / iPlan RT Dosage, all versions.
  • Product Description
    Iplan® cmf-iplan® cranial-iplan® ent-iplan® spine-iplan® stereotaxy-iplan® view: is intended for the visualization, presentation and documentation of medical data. Several modules are included for image processing, image fusion, visualization and segmentation by atlas and intraoperative functional planning. The results can be used for stereotactic surgery guided by images or to process them and visualize them with other devices
  • Manufacturer
    Brainlab AG.

Manufacturer

Brainlab AG.
  • Manufacturer Parent Company (2017)
    Brainlab AG
  • Source
    NIDFSINVIMA