NavLock Trackers Used with StealthStation Systems

  • Modèle / numéro de série
    Products: Part Nos.: Driver, Gray Assembly 9734228 Driver, Orange Assembly 9734259 Driver, Violet Assembly 9734315 Instrument Set NavLock 9734489 Instrument Set, Universal NavLock 9734833 NavLock Kit, Violet 9734837 NavLock Tracker Universal Green 9734734 NavLock Tracker Universal Grey 9734590 NavLock Tracker Universal Orange 9734683 NavLock Tracker Universal Violet 9734682 Tracker Kits, NavLock Universal Green 9734914 Tracker Kits, NavLock Universal Grey 9734906 Tracker Kits, NavLock Universal Orange 9734907 Tracker Kits, NavLock Universal Violet 9734908 NavLock TrackerTM and associated sets and kits: 9735120
  • Description du dispositif
    Stereotactic Systems, Image-Guided, Surgical, Intracranial
  • Manufacturer
  • 1 Event

Fabricant

  • Société-mère du fabricant (2017)
  • 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.
  • Représentant du fabricant
    Medtronic Saudi Arabia
  • Source
    SFDA