Events

Alerta De Seguridad para TomoTherapy Treatment Systems Hi‧Art versions 4.0.x, and HD versions 1.0.x

Según Department of Health, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Hong Kong que fue producido por TomoTherapy Treatment 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
    2011-07-20
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20110721.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: tomotherapy treatment systems hi‧art versions 4.0.X, and hd versions 1.0.X tomotherapy has issued a field safety notice to customers of tomotherapy treatment systems with hi·art versions 4.0.X, and hd versions 1.0.X. there is an anomaly in the software, in which during dicom export of plan level images with a non square exported field of view, an anomaly in the process of squaring the plan level image may cause the image to shift with respect to rois and dose. according to the local supplier, the affected products are available in hong kong. if you are in possession of the affected product, please contact your supplier for necessary actions.

Device

TomoTherapy Treatment Systems Hi‧Art versions 4.0.x, and HD versions 1.0.x
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: [20 Jul 2011] TomoTherapy Treatment Systems Hi‧Art versions 4.0.x, and HD versions 1.0.x
  • Manufacturer
    TomoTherapy Treatment Systems

Manufacturer

TomoTherapy Treatment Systems