Events

Avis De Sécurité sur ARCTIC SUN

Selon Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), ce/cet/cette avis de sécurité concerne un dispositif en/au/aux/à Slovenia qui a été fabriqué par Bard Limited.

Qu'est-ce que c'est?

Les avis de sécurité sont des communications que les fabricants de dispositifs médicaux ou leurs représentants font parvenir en particulier aux travailleurs du secteur médical, mais aussi aux utilisateurs de ces dispositifs. Les avis de sécurité concernent les actions entreprises quant aux dispositifs présents sur le marché et peuvent inclure des rappels et des alertes.

En savoir plus sur les données ici
  • Type d'événement
    Field Safety Notice
  • Pays de l'événement
    Slovenia
  • Source de l'événement
    AMPMDRS
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    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
  • Modèle / numéro de série
    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