Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Medtronic Navigation O-arm O2 Surgical Imaging System Product Catalog Number: Recalled by Medtronic Navigation, Inc.-Littleton Due to O-arm O2 Surgical Imaging System Spatial calibration may...
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 O2 Surgical Imaging System Product Catalog Number: BI-700-02000 Product Usage: The O-arm Surgical Imaging System is a multi-dimensional surgical imaging platform that is designed for use in spine, orthopaedic, and trauma-related surgeries. It provides real-time, intra-operative imaging of a patients anatomy with high quality images and a large field-of-view in both two and three dimensions
Quantity: 14 units
Why Was This Recalled?
O-arm O2 Surgical Imaging System Spatial calibration may be erroneous in Stealth Station navigated images
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