Events

Alerta De Seguridad para BrainSCAN version 5.31 and 5.32

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

¿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
    2011-11-15
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20111116.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 version 5.31 and 5.32 medical device manufacturer, brainlab, has issued a field safety notice advising users of a potential undesirable effect that might occur with the pencil beam dose algorithm of brainscan version 5.31 or version 5.32 under specific conditions. the brainscan pencil beam dose algorithm may overestimate the dose delivered to the target region if both of the following conditions are met: the scatter measurements have been performed according to the technical reference guide (trg) “brainlab physics” (any revision), i.E. the scatter table was measured and implemented without values for equal jaw and mlc field sizes. and in the treatment plan, the margin between jaw position and mlc field shape is set to a value smaller than the default margin of 8mm in leaf movement direction and 2mm in direction perpendicular to leaf movement. as a consequence, a dose lower than planned and intended might be delivered to the patient, potentially resulting in ineffective treatment. 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

BrainSCAN version 5.31 and 5.32
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Brainlab BrainSCAN version 5.31 and 5.32
  • Manufacturer
    Brainlab

Manufacturer

Brainlab