Events

Notificaciones De Seguridad De Campo acerca de CEKA-Preciline

Según Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), este evento ( notificaciones de seguridad de campo ) involucró a un dispositivo médico en Slovenia que fue producido por Alphadent NV.

¿Qué es esto?

Las notificaciones de seguridad de campo son comunicaciones sobre acciones que se pueden estar tomando en relación con un producto que se encuentra en el mercado, enviadas por los fabricantes de dispositivos médicos o sus representantes. Estas notificaciones son principalmente para trabajadores de la salud, pero también para usuarios. Pueden incluir alertas y retiro de equipos.

Más información acerca de la data acá
  • Tipo de evento
    Field Safety Notice
  • Fecha
    2016-05-04
  • País del evento
    Slovenia
  • Fuente del evento
    AMPMDRS
  • Notas / Alertas
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 recall data from the U.S. and Slovenia.
  • Notas adicionales en la data
  • Causa
    On 4 april 2016, alphadent nv decided to withdraw as a result of the withdrawal of the ce conformity certificate for alphadent medical devices. the withdrawal of the ce conformity certificate for alphadent medical devices issued by the notified body does not affect nemko's products and the safety of these medical devices is not compromised. this cancellation is due to a request sent to the notified body by alphadent nv on 13 september 2013 authority to terminate the contract between the company and the notified body. nemko responded to this request on 4 april 2016 and notified the company of the withdrawal of the relevant ce certificate of conformity.   alphadent nv is actively working with the newly notified body to obtain a new ce certificate of conformity for alphadent medical devices.

Device

CEKA-Preciline

Manufacturer

Alphadent NV