Class II — Potential Health Hazard

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

Airo Mobile Intraoperative CT I Airo Recalled by Mobius Imaging, LLC Due to There is a risk that during the transfer...

Date: December 8, 2014
Company: Mobius Imaging, LLC
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 Mobius Imaging, LLC directly.

Affected Products

Airo Mobile Intraoperative CT I Airo; Model #: MobiCT-32. Computed Tomography x-ray system.

Quantity: 21 devices distributed. 15 of these devices affected by the software v. 1.1.1+ patch

Why Was This Recalled?

There is a risk that during the transfer of an image and navigation data to the Brainlab Curve Image Guided Surgery Navigation System after a CT scan, an error may occur, causing either no navigation data or incorrect navigation data being transferred to the curve.

Where Was This Sold?

This product was distributed to 10 states: AK, CA, IL, MA, NY, NC, PA, TX, WA, WV

Affected (10 states)Not affected

About Mobius Imaging, LLC

Mobius Imaging, LLC has 7 total recalls tracked by RecallDetector.

Related Recalls

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