Events

Alerta De Seguridad para Leksell Gammaknife Perfexion and Icon

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

¿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
    2016-04-08
  • Fecha de publicación del evento
    2016-04-08
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20160408.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 leksell gammaknife perfexion and icon the therapeutic goods administration (tga) of australia has posted a medical device safety alert concerning leksell gammaknife perfexion and icon, manufactured by elekta instrument ab. according to the manufacturer, there is a potentially incorrect mounting of frame adapter to coordinate frame. the latches of the frame adapter can be locked even if the locating pins of the frame adapter are not inserted into the corresponding holes in the coordinate frame. if the frame adapter is mounted incorrectly to the coordinate frame and this is not noticed by the user before treatment is started, dose will be delivered in the wrong place by up to 2cm. the manufacturer is advising users that the frame adapter is safe to use provided that the instructions for use are followed and conducted by a trained professional. it is of the highest importance that the frame adapter is mounted to the coordinate frame as described in the applicable instructions for use. the locating pins of the frame adapter shall be inserted into the corresponding holes in the coordinate frame before the three latches are locked. the manufacturer also reminds users that only trained personnel should be involved in mounting the frame adapter. a field safety corrective action will be implemented to facilitate a correct mounting of the frame adapter. for details, please refer to the tga website: http://apps.Tga.Gov.Au/prod/sara/arn-detail.Aspx?k=rc-2016-rn-00410-1 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 8 april 2016.

Device

Leksell Gammaknife Perfexion and Icon
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Elekta Leksell Gammaknife Perfexion and Icon
  • Manufacturer
    Elekta Instrument AB

Manufacturer

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