Events

Avis De Sécurité sur Ceiling pendant SPR 10

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 MZ Liberec a.s..

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
    2015-05-28
  • 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
    Following notification of an incident of failure of an axial segment of a ceiling pendant component, mz liberec is initiating a field safety corrective action. our company will substitute all the axial segments in the field for the new ones. you should receive these new parts along with this notice. we have also increased the inspections of these components as part of the manufacturing process to prevent reoccurrence of similar incidents in the future. it is important that all users inspect the axial segment components for excessive wear. if the any part of the segment has a thickness of less than 1.7 mm, users should cease using the product immediately.

Device

Ceiling pendant SPR 10

Manufacturer

MZ Liberec a.s.