Alerta De Seguridad para 4D Integrated Treatment Console v10.2.3 and Bar-Code Conical Collimator v1.0

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
  • Fecha de publicación del evento
  • País del evento
  • Fuente del evento
  • URL de la fuente del evento
  • 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
    Medical device safety alert: varian 4d integrated treatment console v10.2.3 and bar-code conical collimator v1.0 medical device manufacturer, varian medical systems has issued a medical device safety alert concerning 4d integrated treatment console (4ditc) v10.2.3 and bar-code conical collimator (bccv) v1.0. the plan label is not updated correctly in bccv display if multiple plans are open in 4ditc simultaneously. the bccv display always displays the plan label of the first plan. this situation arises only when multiple conical collimator plans are scheduled to be treated in single session. based on the bccv display, it could be possible that the user may choose a wrong plan from a positioning system that is not interfaced with the 4ditc. if the error of selecting the unintended isocenter in the positioning system went unnoticed, treatment to the incorrect isocenter, with the mu’s and conical collimator size intended for another isocenter could cause a severe under dose or over dose. serious injury or death could occur when a hypo-fractionated radiosurgery field is to be delivered. however, the manufacturer has not received any reports of misadministration. the manufacturer advised the affected users to take the following recommended actions: do not use bccv as a primary reference for identifying the correct plan to be treated. the user should always refer to the 4ditc for identification of the plan and field that has been moded up for treatment. care must be taken at all times in selection of the isocenter in the positioning system. the printed information sheet from the treatment planning system should match the patient name and plan name on the 4ditc before selection of the isocenter in the positioning system. it is imperative that a secondary check of the patient id, plan name and isocenter selection be made before treatment commences. caution should be used when selecting an isocenter in a positioning system that is not interfaced to the 4ditc. any discrepancies in planned versus actual parameters should be brought to the attention of the medical physicist for investigation before treatment begins. one workaround is to schedule one plan per session. the solution of the problem consists of a software upgrade to the bccv from v1.0 to v2.0. according to the local supplier, the affected products were distributed in hong kong. if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 22 november 2012.


  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Varian 4D Integrated Treatment Console v10.2.3 and Bar-Code Conical Collimator v1.0
  • Manufacturer