Alerta De Seguridad para Eclipse 10 (Client builds 10.0.28 and 10.0.34)

Según Department of Health, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Hong Kong que fue producido por Varian Medical Systems.

¿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
  • Fecha
  • País del evento
  • Fuente del evento
  • URL de la fuente del evento
  • Notas / Alertas
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 Hong Kong.
  • Notas adicionales en la data
    Medical Device Safety Alert
  • Causa
    Urgent field safety notice: eclipse 10 (client builds 10.0.28 and 10.0.34) medical device manufacturer, varian medical systems, has issued an urgent field safety notice concerning eclipse 10 (client builds 10.0.28 and 10.0.34). the issue is that the treatment field energy may change from the current selection to a previous selection without user intervention and without invalidating the mu (monitoring unit) or calculated dose distribution. the energy shown or selected by the treatment planner in the fields tab of external beam planning and in the general tab of field properties may differ from the value actually used for dose calculation. this issue is caused by incorrect handling of the energy mode object within the memory cache system used by eclipse external beam planning version 10. varian recommends the users to observe the followings: do not use multiple sessions in eclipse; always close the patient file in eclipse after completing work on the patient record; always close eclipse fully before opening a new patient. furthermore, users should compare the energy shown in dose section and lmc section (if applicable) of the “errors and warnings from last calculation” log in the calculation tab of the field properties dialog with the energy value shown in the fields tab of external beam planning to detect a discrepancy; and confirm and verify all treatment planning calculations. varian is notifying potentially affected customers and preparing a correction for eclipse version 10 to address this issue. according to the supplier, hk is not affected by this field safety notice. if you are in possession of the affected product, please contact your supplier for necessary actions.


  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Eclipse 10 (Client builds 10.0.28 and 10.0.34)
  • Manufacturer