Events

Avis De Sécurité sur TruLight 3000/5000

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
    2016-02-16
  • 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
    Trumpf medical has received notice from a supplier that it may eventually break due to a load in the spring arm welds when exposed to high forces. trumpf medical has not received any complaints or complaints about such failure. the supplier advises performing a visual inspection of the welds every two years as suggested in the july 2010 operating instructions. the inspection should therefore be performed for all operating lights, cameras and mounting systems (mounts) for trumpf medical monitors and for suspension arms.

Device

TruLight 3000/5000

Manufacturer

TRUMPF Medizin Systeme GmbH + Co. KG