Recall Z-1040-2026— Mobius Imaging, LLC

Name: FDA recall Z-1040-2026
Creator: U.S. Food and Drug Administration
Published: 2025-12-04

Class II · Ongoing

Class II FDA medical device recall by Mobius Imaging, LLC, initiated 2025-12-04. It names one FDA 510(k) clearance: K180393. Product: Detachable 10in Pend FRU-1 Pend 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..

Recalling firm: Mobius Imaging, LLC
Classification: Class II
Status: Ongoing
Initiated: 2025-12-04
Firm location: Shirley, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K180393 — AIRO Computed Tomography (CT) X-ray SystemMobius Imaging, LLC·cleared 2018-03-15

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.