FDA-Device2026-01-21Class II
Detachable 10in Pendant Upgrade component for the AIRO Computed Tomography (CT) X-ray System.
Mobius Imaging, LLC
Hazard
AIRO pendant replacement kits and upgrade do not possess the "Safe Hand Position Warning" label.
Sold states
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.
Affected count
26 units
Manufactured in
2 Shaker Rd Ste F100, Shirley, MA, United States
Products
Detachable 10in Pendant Upgrade component for the AIRO Computed Tomography (CT) X-ray System.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1041-2026Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief