Events

Alerta De Seguridad para Eclipse Treatment Planning System: Eclipse Release 6.5 through 10 (versions 7.3.10 to 10.0.34), Model: H48

Según Department of Health, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Hong Kong que fue producido por Varian 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
  • Fecha
    2011-07-08
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20110708.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: eclipse release 6.5 through 10 (versions 7.3.10 to 10.0.34), model: h48 it has come to our attention that varian medical systems, inc. has issued a global field safety notice to customers regarding the captioned planning system used in radiotherapy treatments.  according to the manufacturer, hong kong is affected. in affected eclipse versions, user editing of mlc leaf positions may not automatically invalidate calculated dose distributions. varian is preparing a maintenance release (service pack) of eclipse software to address the problem. if you are in possession of the affected product, please contact your supplier for necessary actions.

Device

Eclipse Treatment Planning System: Eclipse Release 6.5 through 10 (versions 7.3.10 to 10.0.34), M...
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Eclipse Release 6.5 through 10 (versions 7.3.10 to 10.0.34), Model
  • Manufacturer
    Varian Medical Systems, Inc.

Manufacturer

Varian Medical Systems, Inc.