Events

Alerta De Seguridad para Model affected: Monaco Serial numbers affected: Monaco 5.10.2, 5.11.0, 5.11,1

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
    2275
  • Fecha
    2017-01-31
  • 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
    If a new calculation is made after the numbering of the beams is edited and the angle of the wedge is modified, the problem solves itself.
  • Causa
    Incorrect dose after editing beam numbering and wedge angle the dose calculated from the wedge beams can be assigned to the wrong beam. this can occur in a plane with at least two beams using the elekta motorized wedge. when the user changes the numbering (beam index) relative to the two wedge beams that are left with the beams exchanged, and then edit the wedge angle of one of the beams. the numbering of the beams is in the first column of the beams spreadsheet.
  • Acción
    Field Action Code FCAIMS0022 triggered under the responsibility of Elekta Medical Systems Comércio e Serviços Radiotherapy Ltda. Company will make correction in the field.

Device

Model affected: Monaco Serial numbers affected: Monaco 5.10.2, 5.11.0, 5.11,1

Manufacturer

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