Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Medtronic Navigation O-arm 02 surgical x-ray imaging system Recalled by Medtronic Navigation, Inc.-Littleton Due to Review of on-system electronic product labeling and Instr...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Medtronic Navigation, Inc.-Littleton directly.
Affected Products
Medtronic Navigation O-arm 02 surgical x-ray imaging system
Quantity: US - 63
Why Was This Recalled?
Review of on-system electronic product labeling and Instr uctions for Use in response to an internal management concern uncovered gaps in compliance with the requirements for information to be provided to users in 21CFR part 1 020.30(h).
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Medtronic Navigation, Inc.-Littleton
Medtronic Navigation, Inc.-Littleton has 20 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report