Events

Alerta De Seguridad para Elekta XVI 4.5 and 4.6

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

¿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
    2011-10-19
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20111019.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: elekta xvi 4.5 and 4.6 medical device supplier, elekta ltd, issued an important notice to bring users attention to certain precautionary measures required for the operation of elekta xvi. xvi dual registration can inform customers if an organ at risk has moved in relation to the target since the planning stage of treatment. it was discovered at customer site that there is a software error leading to compromise of the dual registration, and this issue applies to release 4.5 and 4.6. an important notice a357 was sent out to all xvi 4.5 and 4.6 users. the notice informs customers using dual registration with compromise how to recognize the issue and avoid it. a later software release of xvi will give a solution to this problem. according to the local supplier, the affected products have been distributed to hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions.

Device

Elekta XVI 4.5 and 4.6
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Elekta XVI 4.5 and 4.6
  • Manufacturer
    Elekta Ltd

Manufacturer

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