Events

Avis De Sécurité sur TruVidia™

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 TRUMPF Medizin Systeme GmbH + Co. KG.

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
  • 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 testing, trumpf medical found that the radiated emissions from the truvidia ™ wireless receiver exceeded the regulatory limits. it is unlikely, but it is possible that the radiated emissions will affect other devices in the operating room, which could cause other devices to malfunction. the frequency of interference and associated risks will depend on the immunity of other devices to the emitted emissions and the nature of the equipment error in the operating room used at that time. trumpf medical has not received any complaints or allegations of injuries related to the issue.

Device

TruVidia™

Manufacturer

TRUMPF Medizin Systeme GmbH + Co. KG