Detachable 10in Pendant Upgrade Component For The Airo Computed Tomography (ct) X-ray System.

Recall Summary Mobius Imaging is recalling detachable 10-inch pendant upgrade components for AIRO CT X-ray systems because they are missing a required "Safe Hand Position Warning" label. This is a Class II recall affecting the pendant replacement kits and upgrades for these medical imaging systems.

Recalling firm

Mobius Imaging, LLC

Product

Detachable 10in Pendant Upgrade component for the AIRO Computed Tomography (CT) X-ray System.

Reason

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

Classification

Class II

Category

consumer product recall

Country

United States

Agency

FDA-DEVICES

Recall date

2025-12-04

Status

Open, Classified

Official recall notice from FDA-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/cd9128aa-e6d5-41ec-b04b-b4416d5b2b40