Events

Safety Alert for Software I PLAN RT

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
    I1508-364
  • Event Number
    2013EBC-0010189
  • Date
    2015-08-04
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=174
  • 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 potentially the automatic calculation of the motor units performed by the software is incorrect under certain conditions of use, and may lead to the administration of the wrong dose, leading to potentially adverse events occurring on the patient.

Device

Software I PLAN RT
  • Model / Serial
  • Product Description
    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
  • Manufacturer Parent Company (2017)
    Brainlab AG
  • Source
    NIDFSINVIMA