Class II — Potential Health Hazard

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. Recalled by Medtronic Navigation, Inc.-Boxborough Due to A mechanical component that supports the O2 gantry...

Date: May 27, 2025
Company: Medtronic Navigation, Inc.-Boxborough
Status: Ongoing
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.-Boxborough directly.

Affected Products

O-arm O2 Imaging System. Mobile X-Ray System.

Quantity: 3 units

Why Was This Recalled?

A mechanical component that supports the O2 gantry to the support structure in affected devices may have been damaged during manufacture.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Medtronic Navigation, Inc.-Boxborough

Medtronic Navigation, Inc.-Boxborough has 1 total recall tracked by RecallDetector.

Related Recalls

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