Events

Alerta De Seguridad para Trade Name: ELEKTA PLANNING SYSTEM Technical Name: ANVISA Registration Number: 80569320003 Hazard Class: III Model Affected: Monaco Serial Numbers Affected: Monaco 5.10.2

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
    2179
  • Fecha
    2016-10-17
  • 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
    Prior to treatment, independent and secondary findings of dose calculation and UM should be performed. Both checks should be standard clinical radiotherapy practices and will detect the problem. 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. Clients should follow the directions in the Field Action release until corrections are implemented.
  • Causa
    Incorrect monitoring unit scale when creating 3d plans using um or dose-weighted modes, if the user changes the number of fractions and / or dose rx desired by the physician and then modifies the angle of the wedge, the value of the one will be scaled incorrectly. the um scale is directly proportional to the fractional change.
  • Acción
    Field Action Code FCA-IMS-0017 triggered under the responsibility of Elekta Medical Systems Comércio e Serviços Radiotherapy Ltda. Company will make correction in the field.

Device

Trade Name: ELEKTA PLANNING SYSTEM Technical Name: ANVISA Registration Number: 80569320003 Hazard...

Manufacturer

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