Avis De Sécurité sur Kodak 2100 and Kodak 2200 Intraoral X-ray Systems

Selon Agency for Medical Products and Medical Devices of Croatia, ce/cet/cette avis de sécurité concerne un dispositif en/au/aux/à Croatia qui a été fabriqué par Carestream Health.

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
  • ID de l'événement
    2014_carestream_health_inc_kodak_2100_and_kodak_2200_system_for_oral_rontgen_1003
  • Date
    2014-01-15
  • Pays de l'événement
  • Source de l'événement
    AMPMDC
  • URL de la source de l'événement
  • Notes / Alertes
    Croatian data is current through September 2015. All of the data comes from the Agency for Medical Products and Medical Devices of Croatia, 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 Croatia.
  • Notes supplémentaires dans les données
    The Agency for Medicinal Products and Medical Devices (HALMED) has received a notice from the manufacturer Carestream Health, Inc. on the possibility of an earlier damage on the junction of scissors arm holder in intraoral Röntgen systems Kodak 2100 and Kodak 2200.
    The manufacturer has discovered the problem on devices delivered in the time period between May 2008 and April 2010 and advises users to check the devices for damage signs even before visit to service engineers.
    Here you may view the safety information addressed to users.

Device

Manufacturer

  • Société-mère du fabricant (2017)
  • Source
    AMPMDC