Events

Avis De Sécurité sur Artis systems

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 Siemens Healthcare GmbH.

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
    2017-01-24
  • 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
    For artis systems with the software versions specified above, a semi-automatic focus switch is implemented. interacting with a special type of defect due to wear in the foci "small" and "micro" (if present). this performs an automatic focus switch when the footswitch is pressed several times. this special system function is not fully described in the operating instructions currently available. if a focus (small/micro) develops a defect, an alternative focus can be selected by pressing the footswitch several times. this enables radiation to be generated once again so that the clinical treatment or diagnosis can be continued.

Device

Artis systems

Manufacturer

Siemens Healthcare GmbH
  • Société-mère du fabricant (2017)
    Siemens Ag
  • Source
    AMPMDRS