Events

Alerta De Seguridad para Software for Surgical / Clinical Planning iPlan. Anvisa Registration n ° 80042070008.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Brainlab AG; Brainlab Ltda..

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • ID del evento
    1628
  • Fecha
    2015-07-10
  • País del evento
    Brazil
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notas / Alertas
    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.
  • Notas adicionales en la 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.
  • Causa
    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.
  • Acción
    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.
  • Empresa matriz del fabricante (2017)
    Brainlab AG
  • Source
    ANVSANVISA