Events

Rappel de Installation medical computerized navigation Stealth Station model C7 (StealthStation S7) with accessories

Selon Federal Service for Surveillance in Healthcare, ce/cet/cette rappel concerne un dispositif en/au/aux/à Russian Federation qui a été fabriqué par Medtronic Navigation Inc..

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    01И-2191/17, ФСЗ 2010/06786
  • Date
    2017-09-05
  • Date de publication de l'événement
    2017-09-06
  • Pays de l'événement
    Russian Federation
  • Source de l'événement
    FSSH
  • URL de la source de l'événement
    http://www.roszdravnadzor.ru/services/unreg
  • Notes / Alertes
    Russian data is current through January 2019. All of the data comes from the Federal Service for Surveillance in Healthcare, 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 Russia.
  • Notes supplémentaires dans les données
    Manufacturer Recall

Device

Installation medical computerized navigation Stealth Station model C7 (StealthStation S7) with ac...

Manufacturer

Medtronic Navigation Inc.
  • Société-mère du fabricant (2017)
    Medtronic plc
  • Commentaire du fabricant
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    FSSH