Events

Recall Or Safety Alert for Radiotherapy treatment planning software from Brainlab iPlan RT Image (versions lower than version 4.1.2) / iPlan RT and BrainSCAN

According to Agencia Española de Medicamentos y Productos Sanitarios (Via FOI), this recall or safety alert involved a device in Spain 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
    Recall / Safety Alert
  • Date
    2015-10-28
  • Event Country
    Spain
  • Event Source
    AEMPSVFOI
  • Notes / Alerts
    The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, 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 Spain.
  • Extra notes in the data
  • Action
    Possibility that the planning of the treatment is misleading and that the volumes of interest are incorrectly defined when using a set of images not compatible with the radiotherapy treatment planning software, manufactured by Brainlab AG, Germany.

Device

Radiotherapy treatment planning software from Brainlab iPlan RT Image (versions lower than versio...

Manufacturer

Brainlab AG
  • Manufacturer Parent Company (2017)
    Brainlab AG
  • Source
    AEMPSVFOI