Events

Avis De Sécurité sur VESA 75 / 100 adaptation with rotation

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 ITD 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
  • 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
    We have within the framework of our ongoing quality checks unfortunately ascertained that in the case of the article "vesa 75 / 100 adaptation with rotation", which is part of our monitor mounts and support arms, the riveting of the rotation may possibly not have been carried out according to the specifications. in exceptional cases, it can lead to a loosening thereof, respectively to a loosening of the connection plate in the case of continuous use, which can in turn lead to a risk to patients, users or third parties. for this reason we have decided to carry out a replacement action. on account of the fact that no case of damage has hitherto occurred in practice, this relates to preventive measure with regard to our deliveries, for the limited time period from may to november 2015. based on our records, we have discerned that you have been supplied by us, with the affected products, during the aforementioned time period. a detailed list of relevant orders can be found in an annex to this letter. .

Device

VESA 75 / 100 adaptation with rotation
  • Modèle / numéro de série
  • Manufacturer
    ITD GmbH

Manufacturer

ITD GmbH
  • Société-mère du fabricant (2017)
    Itd Gmbh
  • Source
    AMPMDRS