Events

Alerta De Seguridad para TrueBeam and TrueBeam STx

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
    2011-11-08
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20111108.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: varian truebeam and truebeam stx medical device manufacturer, varian, has issued an urgent medical device correction concerning truebeam and truebeam stx. it has been identified with the truebeam and truebeam stx systems where, under certain tuning conditions, the electron beam emerging from the bend magnet may have an elongated spot shape. the presence of this elongated beam spot shape can be detected by a larger than expected difference in the penumbra between the radial and transverse planes, as measured by beam profile scans. varian is notifying all possibly affected customers with the notice and developing a correction for this issue. according to the local supplier, the affected device has been distributed in hong kong. if you are in possession of the affected products, please contact supplier for necessary actions.

Device

TrueBeam and TrueBeam STx
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Varian TrueBeam and TrueBeam STx
  • Manufacturer
    Varian

Manufacturer

Varian