Events

Avis De Sécurité sur Artis one 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 Shenzhen Magnetic Resonance Ltd.

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
    2017-07-12
  • 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
    During regular field observation, er (examination room) monitor display was identified with blinking, blue/black screen issues. what is the impact on system operation and what is the potential risk? in case the problem occurs, the impact to an ongoing procedure may be limited functionality up to failing of a system. in most of cases, a power circle (shutdown and then power on) can bring system back to normal. in very rare case while power circle does not work, it might be necessary to cancel or restart a clinical procedure or transferring it to a functioning system.

Device

Artis one systems

Manufacturer

Siemens Shenzhen Magnetic Resonance Ltd
  • Société-mère du fabricant (2017)
    Siemens Ag
  • Source
    AMPMDRS