Events

Alerta De Seguridad para Digital Accelerators with Electrons and Beam Modulator MLCi/MLCi2

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

¿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
    2013-07-05
  • Fecha de publicación del evento
    2013-07-05
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20130705a.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
    Medical device safety alert: elekta digital accelerators with electrons and beam modulator mlci/mlci2 the australia therapeutic goods administration (tga) has posted a medical device safety alert concerning all digital accelerators with electrons and beam modulator, mlci/mlci2, agility or asymmetric heads, manufactured by elekta. according to the tga, the manufacturer has advised that some digital accelerators have increased electron applicator auto-tracking settings in the field, to values greater than the factory-set defaults, which can result in an increase of electron applicator radiation leakage in the patient plane, as well as around the applicator. the manufacturer is asking users to check all affected machines against the default auto-tracking settings. a software update will be provided as a permanent fix. for details, please visit the following tga website: http://www.Tga.Gov.Au/sara/arn-detail.Aspx?k=rc-2013-rn-00667-1 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 05 july 2013.

Device

Digital Accelerators with Electrons and Beam Modulator MLCi/MLCi2
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Elekta Digital Accelerators with Electrons and Beam Modulator MLCi/MLCi2
  • Manufacturer
    Elekta

Manufacturer

Elekta
  • Empresa matriz del fabricante (2017)
    Elekta AB
  • Source
    DH