Events

Safety Alert for Software for Surgical / Clinical Planning iPlan. Anvisa Registration n ° 80042070008.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Brainlab AG; Brainlab Ltda..

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
    1628
  • Date
    2015-07-10
  • Event Country
    Brazil
  • Event Source
    ANVISA
  • Event Source URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alerts
    Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 data from the U.S. and Brazil.
  • Extra notes in the data
    Automatic calculation of motor units may potentially be incorrect in the Brainlab iPlan RT Dose planning software if all of the following conditions are met: 1 - Multiple PTVs are planned in the treatment plan; 2 - at least one treatment group or treatment element is locked to prevent further modifications; 3 - for each PTV, with a treatment group or at least one locked treatment element, assigned with dose restriction at the point of 50% of the volume deviated by more than 5% from the current dose in the 50% volume. The problem may result in an incorrect treatment plan, which may lead to an incorrect treatment, for example, an overdose in the salivable tissue or sub-dose in the tumor tissue.
  • Reason
    The automatic calculation of motor units may potentially be incorrect in the planning software of the brainlab iplan rt if some conditions of use may lead to incorrect dosing.
  • Action
    The company is developing a new version of software to fix the problem. Recommendations for product users: (1) Carefully check the prescription dialog if the restriction points for all PTVs / boosts are met as expected before approving and exporting, especially if the plan has multiple PTVs / boosts and at least one element / treatment group blocked; (2) Prior to approval and export, the entire plan needs to be reviewed. Note that at any stage the dose distribution in the software reflects the dose actually being delivered by the treatment plan.

Device

Software for Surgical / Clinical Planning iPlan. Anvisa Registration n ° 80042070008.

Manufacturer

Brainlab AG; Brainlab Ltda.
  • Manufacturer Parent Company (2017)
    Brainlab AG
  • Source
    ANVSANVISA