Events

Alerta De Seguridad para BrainSCAN and iPlan RT treatment planning software versions

Según Department of Health, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Hong Kong que fue producido por Brainlab AG.

¿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
    2012-03-20
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120320a.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: brainlab brainscan and iplan rt treatment planning software versions medical device manufacturer, brainlab ag, has issued a field safety notice concerning all brainlab brainscan and iplan rt treatment planning software versions. according to brainlab, the accuracy of the brainlab radiotherapy treatment planning software was not within clinically desirable limits for very small multi-leaf-collimator field sizes. if not recognized by the user with the recommended treatment plan quality assurance, the irradiation of such a treatment plan might lead to serious injury of the patient and/or ineffective treatment. brainlab is notifying affected customers with a field safety notice and will provide an updated instructions for use to them. the tentative availability of the update will be in june 2012. according to the local supplier, the affected devices were distributed to hong kong. if you are in possession of the products, please contact your supplier for necessary actions.

Device

BrainSCAN and iPlan RT treatment planning software versions
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Brainlab BrainSCAN and iPlan RT treatment planning software versions
  • Manufacturer
    Brainlab AG

Manufacturer

Brainlab AG