Events

Notificaciones De Seguridad De Campo acerca de ARCTIC SUN

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 Bard Limited.

¿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
  • 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
    The tag supplement provides advice that regular maintenance and maintenance of the arctic sun® 5000 temperature monitoring system is recommended to reduce the likelihood of failure of certain components. this letter also details the preventative maintenance program offered by bard to assist in the regular servicing and maintenance of the device. this is not a product recall, and bard does not require you to withdraw from the market and return any unit as a result of this notice.

Device

ARCTIC SUN
  • Modelo / Serial
    ARCTIC SUN® 5000 Temperature Control System (220-240V for Europe) 5000-01-01 ARCTIC SUN® 5000 Temperature Control System (220-240V for UK) 5000-01-02 ARCTIC SUN® 5000 Temperature Control System (230 V for Switzerland) 5000-01-07 ARCTIC SUN® 5000 Temperature Control System (230 V for South Africa) 5000-01-08
  • Manufacturer
    Bard Limited

Manufacturer

Bard Limited