Events

Alerta De Seguridad para Trade name: ELEKTA PLANNING SYSTEM Technical name: ELEKTA PLANNING SYSTEM ANVISA registration number: 80569320003 Hazard class: III Model affected: Monaco Serial numbers affected: Monaco 5.11 and 5.20

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..

¿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
    2065
  • Fecha
    2016-12-05
  • 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
    The problem can be avoided by forcing a new calculation on Monaco® (change the spacing of the dose calculation grid and return again) when any change in wedge angle is made. Prior to treatment, independent verifications of the dose calculation and the secondary UMs should be performed. Both checks should be standard clinical radiotherapy practices and will detect the problem.
  • Causa
    The dose can be incorrectly calculated by using the reset function on monaco®. when creating 3d plans using the dose weighing mode, if you reset the plane, select "reset" and then change the angle of the wedge, the plane dose and the monitor units (um) must be returned to their original values ​​before the reset is performed. however, the system correctly restores the edited wedge fields, but incorrectly applies the readjusted values ​​to all other beams in the plane.
  • Acción
    Field Action Code FCA-IMS-0018 triggered under the responsibility of Elekta Medical. Company will make correction in the field.

Device

Trade name: ELEKTA PLANNING SYSTEM Technical name: ELEKTA PLANNING SYSTEM ANVISA registration num...

Manufacturer

IMPAC Medical Systems, Inc.
  • Empresa matriz del fabricante (2017)
    Elekta AB
  • Source
    ANVSANVISA