Events

Avis De Sécurité sur DXR

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 Philips Medical Systems.

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
    2017-07-14
  • 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
    Because reliability and safety are always at the forefront of philips, we regularly monitor the performance of our products. during recent assessments of the mobile detector holder, we have identified a possible defect that may affect the performance of the equipment under certain conditions. we would like to inform you of the following letter:   • what is the disadvantage and under what conditions it may occur, • what measures can be taken to prevent or limit the problem, • what actions philips will address the shortcoming.

Device

DXR

Manufacturer

Philips Medical Systems
  • Société-mère du fabricant (2017)
    Philips
  • Source
    AMPMDRS