Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
O-arm" O2 Imaging System Recalled by Medtronic Navigation, Inc.-Littleton Due to Due to a manufacturing issue affecting particular 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, Product Number/CFN: BI-700-02000
Quantity: 90
Why Was This Recalled?
Due to a manufacturing issue affecting particular O-arm" O2 Imaging Systems, Medtronic has determined that the gantry tractor motor drive belt may loosen over an extended number of uses at a higher frequency in these systems. If the belt loosens, it may result in rotation of 3D images about the gantry isocenter. While the 3D image is anatomically accurate within the image itself and may be used to confirm therapy, its electronic registered location may be rotated relative to the actual physical position of the patient.
Where Was This Sold?
This product was distributed to 27 states: AR, CA, CO, CT, FL, ID, IL, IN, KS, KY, MI, MN, MO, NE, NY, NC, ND, OH, OR, PA, SC, SD, TX, VA, WA, WV, WI
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