Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
The O-arm O2 Imaging System is a mobile x-ray system Recalled by Medtronic Navigation, Inc.-Littleton Due to Ground cable installed incorrectly.
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
The O-arm O2 Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging for adult and pediatric patients weighing 60 lbs. or greater and having an abdominal thickness greater than 16 cm and is intended to be used where a physician benefits from 2D and 3D information of anatomic structures and objects with high x-ray attenuation such as bony anatomy and metallic objects.
Quantity: 28 units
Why Was This Recalled?
Ground cable installed incorrectly.
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