Events

translation missing: fr.activerecord.attributes.event.titles.recall_field_safety_notice

Selon Saudi Food & Drug Authority, ce/cet/cette translation missing: fr.activerecord.attributes.event.types.recall_field_safety_notice concerne un dispositif en/au/aux/à Saudi Arabia qui a été fabriqué par C R Bard Inc.

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
    Recall / Field Safety Notice
  • ID de l'événement
    mdprc 039 08 17 000
  • Date de mise en oeuvre de l'événement
    2017-08-15
  • Pays de l'événement
    Saudi Arabia
  • Source de l'événement
    SFDA
  • URL de la source de l'événement
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=11405
  • Notes / Alertes
    Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, 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 Saudi Arabia.
  • Notes supplémentaires dans les données
    Report Source: NCMDR
    SFDA urges all hospitals that have devices subjected to recall, to contact the company.
  • Cause
    Bard is issuing a field safety notice to advise users of an update to the instructions for use for the arctic sun® 5000 temperature management system, per the enclosed labelling addendum. this labelling addendum should be used together with the current operator’s manual and service manual for your device and will be included in the labelling of all future units distributed by bard. the labelling addendum advises that periodic servicing and maintenance of the arctic sun® 5000 temperature management system is recommended to reduce the risk of failure of certain components.

Device

ARCTIC SUN® 5000 Temperature Management System
  • Modèle / numéro de série
    Product Codes: 5000-01-01, 5000-01-02, 5000-01-07, 5000-01-08
  • Description du dispositif
    Warming/Cooling Units, Patient
  • Manufacturer
    C R Bard Inc

Manufacturer

C R Bard Inc