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MEDTRONIC NAVIGATION, INC. (Boxborough)

United Statesfrom the FDA registration address FDA establishment FEI 3004785967

Devices
0
Registrations
FDA
FDA recalls
22 ongoing

No devices from this company are in the catalogue yet.

Company details

FDA FEI number
3004785967
Address
200 Beaver Brook Rd, Boxborough, MA, 01719

FDA recalls2

Recalls are matched to the firm by name. FDA recall data as of 22 Oct 2026.

Recalls initiated per year

  • 2017 0
  • 2018 0
  • 2019 0
  • 2020 0
  • 2021 0
  • 2022 0
  • 2023 0
  • 2024 0
  • 2025 1
  • 2026 1

  • 2026

    • 19 May 2026 Z-2451-2026 Class II Ongoing Potential for image artifacts caused by an anomaly in the O-arm O2 Imaging System s detector panel firmware. Distribution: Worldwide distribution - US Nationwide and the countries of Albania, Algeria, Angola, Argentina, Australia, Austria,…
      Full distribution text Worldwide distribution - US Nationwide and the countries of Albania, Algeria, Angola, Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Canary Islands, Chile, China, Cyprus, Czech Republic, Denmark, Finland, France, Georgia, Germany, Greece, Guatemala, Hong Kong, India, Indonesia, Iraq, Israel, Italy, Japan, Jordan, Kazakhstan, Kuwait, Libya, Malaysia, Mexico, Morocco, Nepal, Netherlands, Philippines, Poland, Portugal, Puerto Rico, Romania, Russia, Saudi Arabia, Singapore, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Vietnam.
      Submission number: K240465

  • 2025

    • 27 May 2025 Z-2101-2025 Class II Ongoing A mechanical component that supports the O2 gantry to the support structure in affected devices may have been damaged during manufacture. Distribution: US Nationwide distribution in the states of IN, MN, MS. Submission number: K240465

This is an FDA establishment record without devices in deviCERTS.