Class II — Potential Health Hazard

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

Detachable 10in Pend FRU-1 Pend component for the AIRO Computed Recalled by Mobius Imaging, LLC Due to AIRO pendant replacement kits and upgrade do not...

Date: December 4, 2025
Company: Mobius Imaging, LLC
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 Mobius Imaging, LLC directly.

Affected Products

Detachable 10in Pend FRU-1 Pend component for the AIRO Computed Tomography (CT) X-ray System.

Quantity: 101 units

Why Was This Recalled?

AIRO pendant replacement kits and upgrade do not possess the "Safe Hand Position Warning" label.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 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