Events

Alerta De Seguridad para ELEKTA SOFTWARE FOR TREATMENT PLANNING. Models: MONACO and FOCAL. Anvisa Registry: 80569320003. (Update on 09/09/2014: Added 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 IMPAC Medical Systems, Inc; Elekta Medical Systems Comércio e Serviços para Radioterapia 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
    1412
  • Fecha
    2014-08-12
  • 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
    As a consequence of the problem, the plan exported by the DICOM and the application of subsequent treatments would not correspond to the approved treatment plan. Thus, areas of the patient who should not receive doses may be treated and areas that should be treated may receive a dose that is higher or lower than the correct dose. According to the company's risk assessment, there is a remote possibility that the problem will lead to serious adverse health consequences.
  • Causa
    Incorrect handling when performing a dicom export of arcs using multiple field sequencing.
  • Acción
    The company is providing a software fix for the problem. To avoid adverse events, do not use 180 ° as the starting angle of the gantry of the second bow - using 180.1 ° or 179.9 ° as the initial gantry angle completely eliminates the problem. Users should follow the guidance given in the Important Field Safety Notice and confirm receipt of the notice for the local Elekta contact as soon as possible. The important Notice of Field Security disclosed by the company is available at: http://portal.anvisa.gov.br/wps/connect/d8e83d004513a40c9130d7004acc0eea/Messagem+de+Alerta+%282%29.pdf?MOD=AJPERES

Device

ELEKTA SOFTWARE FOR TREATMENT PLANNING. Models: MONACO and FOCAL. Anvisa Registry: 80569320003. (...

Manufacturer

IMPAC Medical Systems, Inc; Elekta Medical Systems Comércio e Serviços para Radioterapia Ltda.
  • Empresa matriz del fabricante (2017)
    Elekta AB
  • Source
    ANVSANVISA