Class II

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

Mobius Imaging, LLC · December 4, 2025

Reason for Recall

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

Distribution

US Nationwide distribution in the states of AK, AL, AZ, CA, CO, CT, DC, FL, IL, KY, MA, MD, MI, MN, MO, NC, NY, OH, PA, RI, SC, TN, TX, UT, VA, WI.

States Affected

NATIONWIDE

Quantity Affected

26 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-1041-2026

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.