Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Medtronic O-arm Imaging System Product Usage: image-intensified fluoroscopic x-ray system Recalled by Medtronic Navigation, Inc. Due to Potential failure of the braking system that controls...

Date: January 31, 2013
Company: Medtronic Navigation, Inc.
Status: Terminated
Source: FDA (Device)

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. directly.

Affected Products

Medtronic O-arm Imaging System Product Usage: image-intensified fluoroscopic x-ray system, mobile

Quantity: 463 units

Why Was This Recalled?

Potential failure of the braking system that controls the O-arm Imaging System gantry movement in the vertical direction

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Medtronic Navigation, Inc.

Medtronic Navigation, Inc. has 91 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report