Avis De Sécurité sur TruLight 3000, TruLight 5000, iLED 3, iLED 5 and 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
  • Date
    2016-01-06
  • Pays de l'événement
  • 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
    Trumpf medical has received information that separates iled and trulight lighting systems from central axes and as a result they fall to the ground. the attachments occurred while installing the lights in preparation for surgery. the crash resulted in a single user being injured.

Device

  • Modèle / numéro de série
    iLED Single 4028110 iLED Duo 4028210 iLED Trio / Quad 4028310 TruLight Single 4038110 TruLight Duo 4038210 TruLight Trio / Quad 4038310 iLED Single (US / Canada only) 1565068 iLED Duo (US / Canada only) 1565160 iLED Trio / Quad (US / Canada only) 1565161 TruLight Single (US / Canada only) 1574759 TruLight Duo (US / Canada only) 1574850 TruLight Trio / Quad (US / Canada only) 1574851 TruVidia Arm 1532466
  • Manufacturer

Manufacturer