Events

Alerta De Seguridad para Trade name: ELEKTA PLANNING SYSTEM; ANVISA registration number: 80569320003; Risk class: III; Affected model (s): Monaco version 5.10; lot / series (local distribution district / UF): 5.10.02 (4 in São Paulo-SP, 1 in Belo Horizonte-MG, 1 in Santa Maria-RS); 5.10.00 (1 in Rio de Janeiro-RJ); 5.10.02 (1 in Pouso Alegre-MG)

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 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
    1906
  • Fecha
    2016-06-07
  • 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
    Case of doubts about this action phone call: 8008784267
  • Causa
    Incorrect field size when dicom exporting monaco plan with composite field sequencing will fit in the port format when they remain where they are set. this runs when the shape of the door used to define or edit the mlc positions extend beyond or within the current grip positions. the defect was triggered when using an outdated workflow for the imrt planning for the future imrt which requires the creation of multiple beams for the same gantry angle with a single mlc format defined for each beam. these beams are then exported using cfs. there may be a possibility of a change in treatment planning, which could change the dose site and the amount received.
  • Acción
    Action code FCA-IMS-0013. Software update /// Letter to customers elaborated on 06/03/2016.

Device

Trade name: ELEKTA PLANNING SYSTEM; ANVISA registration number: 80569320003; Risk class: III; Aff...

Manufacturer

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