Alerta De Seguridad para Radiation Treatment Planning System / FOCAL Model. Anvisa Registration No. 80569320008. Version 4.80.00 of the FOCAL model.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por ELEKTA MEDICAL SYSTEMS COMÉRCIO E SERVIÇOS PARA RADIOTERAPIA LTDA.; IMPAC Medical Systems, Inc.

¿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
    1489
  • Fecha
    2015-01-12
  • País del evento
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
  • 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
    When a CT phantom is scanned and the images are transferred to the Focal, you can sample the densities using the Image Statistics tool in Focal. In the case where the thickness of the CT slice is not equal to the spacing of the CT slice, the Image Statistics tool will report an incorrect HU. If you base your CT-to-ED file on this incorrect density information, this will result in errors in the calculation of the dose. The magnitude of the error in the dose calculation will depend on the magnitude of the HU error. The problem occurs when the CT Slice Spacing is not equal to the CT Slice Thickness, and the Image Statistics tool information is used to populate the CT-to-ED file. According to the company's risk assessment, Focal will assign an incorrect density that will lead to errors in the dose, which can result in adverse consequences without serious health. Check information in the Important Notice to the User, available at http://portal.anvisa.gov.br/wps/connect/57699e8046ec7179a7c6b741cdd33a01/Amanda+Importante+to+Usu%C3%A3rio+-+FOCAL+7.pdf?MOD = AJPERES.
  • Causa
    Possibility of error in the calculation of the therapeutic dose of radiation, under specific conditions of use of the product.
  • Acción
    Equipment operators must read, complete and send the Important User Notice form to Elekta as soon as possible (30-day deadline). The solution (software update) should be implemented by Elekta technical assistance as soon as possible. The Important User Notice form is available at http://portal.anvisa.gov.br/wps/wcm/connect/57699e8046ec7179a7c6b741cdd33a01/Amanda+Importante+to+Usu%C3%A3rio++++++++++++++++++.pdf?MOD = AJPERES.