Events

Alerta De Seguridad para 4d integrated treatment console v8.6 or 8.8 in combination with treatment planning systems

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
    2012-04-18
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120418a.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 (4ditc) v8.6 or 8.8 in combination with treatment planning systems medical device manufacturer, varian medical systems, has issued an urgent field safety notice concerning 4d integrated treatment console (4ditc) v 8.6 or 8.8 in combination with treatment planning systems. it has been identified that in certain configurations, the 4ditc can interpret a rapidarctm or vmat treatment field as 3d conformal arc treatment plan. if it happens, the field will be delivered with a constant dose rate and gantry speed for the entire duration of the delivery, which can lead to delivered dose being different from the planned dose. according to varian, this will only happen when the change in mu/deg between consecutive control points is small. in other words, it can only happen when the dose rate or gantry speed vary in a very smooth and progressive way for the entire rapidarc field. rapidarctm treatment plans created with eclipse 8.2 and higher or potentially vmat treatment plans created with 3rd party treatment planning systems, when delivered on the 4ditc v8.6 and v8.8 can be incorrectly identified as 3d conformal arc treatment plan. varian is now notifying all affected customers and will update the 4ditc software to address issues related to proper recording of treatment information from varian machines. according to the local supplier, the affected devices have been distributed in hong kong. if you are in possession of the affected product, please contact your supplier for necessary actions.

Device

4d integrated treatment console v8.6 or 8.8 in combination with treatment planning systems
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: 4D Integrated Treatment Console (4DITC) v8.6 or 8.8 in combination with treatment planning systems
  • Manufacturer
    Varian Medical Systems

Manufacturer

Varian Medical Systems