Events

Alerta De Seguridad para Trade name: iPlan Surgical / Clinical Planning Software, brand Brainlab ///. Technical name: Surgical / Clinical Planning Software ///. ANVISA registration number: 80042070008 ///. Risk class: III - High Risk

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

¿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
    2017
  • Fecha
    2016-10-07
  • 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
    1) Immediately check the Leaf Shift Static value on all of your machine profiles on the iPlan RT Dose for MLC Elekta Agility: Ensure that this value is set to "0 mm". If another value is set, change this specific value to 0 (zero) to permanently resolve the potential problem described. 2) Return the Customer Response Form attached to the Product Notification to Brainlab.
  • Causa
    Potential effect of incorrect calculation of dose distribution when using treatment planning iplan rt dose with multiline collimator (mlc) elekta agility under specific circumstances. if the effect occurs for these specific treatment plans and is not detected by the user with the corresponding treatment-specific quality control, this may result in an unrecognized accumulated dose leak and not considered in small tissue regions, which may exceed the clinically acceptable limits and essentially causing undesirable long-lasting effects to the patient. no occurrences have been reported to brainlab by users regarding unwanted dose distributions administered to patients due to this problem.
  • Acción
    Field Action Code CAPA-20160909-001728 triggered under the responsibility of the company Brainlab Ltda. Company is making correction in field of software update.

Device

Trade name: iPlan Surgical / Clinical Planning Software, brand Brainlab ///. Technical name: Surg...

Manufacturer

Brainlab Ltda; Brainlab AG
  • Empresa matriz del fabricante (2017)
    Brainlab AG
  • Source
    ANVSANVISA