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 and above

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
    2180
  • Fecha
    2016-12-05
  • País del evento
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
  • 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
    Recommended user action: The problem can be avoided if the user performs the following actions: - Following the edits of the contour, perform an "Unload All" and reload the plan before performing the dose calculation.
  • Causa
    Contours are not handled correctly if the tc data set contains cuts with coordinates dicom z d xx.X50mm. if ct data has cuts occurring in the xx.X50mm position, there may be portions of the volume where there is an incompatibility between the contour graphics displayed on the screen and the contour data used during dose optimization and calculation. unloading and reloading patient data solves the problem.
  • Acción
    Field Action Code FCA-IMS-0019 triggered under the responsibility of Elekta Medical Systems Comércio e Serviços Radiotherapy Ltda. Company will make correction in the field.

Manufacturer