Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
O-arm O2 Imaging System-Mobile x-ray system designed for 2D fluoroscopic Recalled by Medtronic Navigation, Inc.-Littleton Due to Potential for an electrical component of the O-arm"...
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
O-arm O2 Imaging System-Mobile x-ray system designed for 2D fluoroscopic and 3D imaging for adult and pediatric patients. Product Number: BI70002000
Quantity: 20 units
Why Was This Recalled?
Potential for an electrical component of the O-arm" O2 Imaging System to intermittently shut off,failure can cause the potential for surgical delay, additional imaging, cancellation and rescheduling of surgery, or completion of surgery without the benefit of image guidance.
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