Events

Alerta De Seguridad para Eclipse Treatment Planning System, 7.3, 8.0, 8.1, 8.2, 8.6, 8.9, 10.0

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
    2012-03-07
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120307b.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: eclipse treatment planning system, 7.3, 8.0, 8.1, 8.2, 8.6, 8.9, 10.0 medical device manufacturer, varian medical systems, has issued a field safety notice concerning eclipse treatment planning system, 7.3, 8.0, 8.1, 8.2, 8.6, 8.9, 10.0. according to varian, an anomaly has been identified with the eclipse treatment planning system (in both external beam planning and irreg tasks) when planning for the machines that have multileaf collimator (mlc) device replacing upper and/or lower collimator jaws. for these machines modeled with ‘virtual jaws’ (refer to“collimator jaws” replaced by mlc) , positioning a virtual jaw inside the mlc aperture will result in an incorrect dose distribution within eclipse. varian is identifying possible technical solutions for this issue. according to the local supplier, the affected devices have been distributed in hong kong. if you are in possession of the products, please contact your supplier for necessary actions.

Device

Eclipse Treatment Planning System, 7.3, 8.0, 8.1, 8.2, 8.6, 8.9, 10.0
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Eclipse Treatment Planning System, 7.3, 8.0, 8.1, 8.2, 8.6, 8.9, 10.0
  • Manufacturer
    Varian Medical Systems

Manufacturer

Varian Medical Systems