Events

Avis De Sécurité sur DRX-Revolution

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 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
  • Date
    2017-05-29
  • 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
    Carestream health has identified a problem with drx-revolution mobile x-ray systems that could separate the tube assembly and the fixture. carestream has found one device that works for this the assembly is missing four screws because they were not installed during production. carestream believes there are probably no other drx-revolution mobile x-ray systems missing this step. there was no injury as a result of this fault, but if the hose falls on the person it can be damaged.

Device

DRX-Revolution

Manufacturer

Carestream Health
  • Société-mère du fabricant (2017)
    ONEX Corp
  • Source
    AMPMDRS