Events

Alerta De Seguridad para 4D Integrated Treatment Console v8.6 with ARIA RT Chart v8.5, all of 4DITC v8.3

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

¿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
    2011-07-26
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20110726.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: 4d integrated treatment console v8.6 with aria rt chart v8.5, all of 4ditc v8.3 medical device manufacturer, varian, has issued an urgent field safety notice to the customers of 4ditc v8.6 with aria rt chart v8.5, all of 4ditc v8.3. the 4ditc may erratically fail to load the planned wedge without warning or notification when receiving an approved plan from the oncology information system (ois). delivery of a treatment field without the planned and calculated wedge filter could result in an over dosage for that beam and potentially an unintended dose uniformity of the target treatment volume. this errant behavior may occur with the above-affected releases of 4d integrated treatment console, v8.6 or earlier. to avoid the issue, the manufacturer recommended customers to make workflow adjustments in their planning, scheduling, and delivery portions prior to delivering a wedge field treatment. according to the local supplier, hong kong is affected. if you are in possession of the affected product, please contact your supplier for necessary actions.

Device

4D Integrated Treatment Console v8.6 with ARIA RT Chart v8.5, all of 4DITC v8.3
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: [26 Jul 2011] 4D Integrated Treatment Console v8.6 with ARIA RT Chart v8.5, all of 4DITC v8.3
  • Manufacturer
    Varian

Manufacturer

Varian