Events

Alerta De Seguridad para Eclipse™ Treatment Planning System

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
    2012-03-20
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120320c.html
  • 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
    Field safety notice: varian eclipse™ treatment planning system medical device manufacturer, varian medical systems (varian), has issued a field safety notice concerning eclipse™ treatment planning system, versions 7.3, 8.0, 8.1, 8.2, 8.6, 8.9 and 10.0. according to varian, an anomaly has been identified with the eclipse™ treatment planning system where the calculated dose distribution is not updated or invalidated when a recalculation or reload is performed while the compensator or fluence editor is open. the issue may go unnoticed. proceeding to approve and treat with such a plan can result in the delivered dose distribution not matching the calculated dose distribution. varian is notifying all possibly affected customers with a field safety notice. according to varian, the affected devices were distributed to hong kong. if you are in possession of the products, please contact your supplier for necessary actions.

Device

Eclipse™ Treatment Planning System
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Varian FastPlan treatment planning system
  • Manufacturer
    Varian Medical Systems

Manufacturer

Varian Medical Systems