Events

Alerta De Seguridad para 4D Integrated Treatment Console and TrueBeam

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_20120307a.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 and truebeam medical device manufacturer, varian medical systems, has issued a field safety notice concerning 4d integrated treatment console (4ditc) and truebeam. varian has identified potential discrepancies in intensity modulated radiotherapy (imrt) complete irradiated area outline (ciao) outline visualization between treatment applications (4d integrated treatment console (4ditc), am editor, on-board imager, portalvision and truebeam), and treatment planning & oncology information system applications (eclipse, aria, rtchart, off-line image review). according to varian, the discrepancy is a display issue that is sometimes seen when an ad-hoc image template has been added, after the plan has been loaded on the 4ditc. none of the reported discrepancies affect the delivered dose to the imrt field, and the planned mlc and the actual mlc used for treatment are correct. p> 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

4D Integrated Treatment Console and TrueBeam
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: 4D Integrated Treatment Console and TrueBeam
  • Manufacturer
    Varian Medical Systems

Manufacturer

Varian Medical Systems