Events

Notificaciones De Seguridad De Campo acerca de On-Board Imager® with CBCT

Según Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), este evento ( notificaciones de seguridad de campo ) involucró a un dispositivo médico en Slovenia que fue producido por Varian Medical Systems.

¿Qué es esto?

Las notificaciones de seguridad de campo son comunicaciones sobre acciones que se pueden estar tomando en relación con un producto que se encuentra en el mercado, enviadas por los fabricantes de dispositivos médicos o sus representantes. Estas notificaciones son principalmente para trabajadores de la salud, pero también para usuarios. Pueden incluir alertas y retiro de equipos.

Más información acerca de la data acá
  • Tipo de evento
    Field Safety Notice
  • Fecha
    2016-02-08
  • País del evento
    Slovenia
  • Fuente del evento
    AMPMDRS
  • Notas / Alertas
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 recall data from the U.S. and Slovenia.
  • Notas adicionales en la data
  • Causa
    Varian has received several reports of the on-board imager® cone beam ct [cbct] acquisition stalling preventing reconstruction of the image. a repeat scan will be required. there are two possible symptoms. 1) the cbct application stops updating the display during acquisition. 2) an exception occurs during the acquisition. although cbct projections will have been acquired, it will not be possible to generate the reconstructed cbct and the scan must be repeated. there have been no misadministration or injuries reported due to this issue. .

Device

On-Board Imager® with CBCT

Manufacturer

Varian Medical Systems