STEALTHSTATION S7 - SOFTWARE CRANIAL

  • Model / Serial
    Model Catalog: 9733986 (Lot serial: All lots contact mfg)
  • Product Description
    Medtronic Navigation StealthStationr S7 and i7 Systems and Planning Station containing FrameLink Software Version 5.4
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    BRAMPTON
  • Manufacturer Parent Company (2017)
  • Manufacturer comment
    “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
    HC