FDA-Device2026-01-21Class IIMISBRANDING
Mobius Imaging AIRO CT pendant upgrade lacks safety warning label
What this means
Mobius Imaging's detachable 10-inch pendant upgrade kits for AIRO Computed Tomography systems are missing a required "Safe Hand Position Warning" label. This label is important for safe operation of the equipment. The affected units were distributed nationwide.
- If you operate an AIRO CT system with a pendant upgrade, check the serial number against the list provided by the FDA
- Contact Mobius Imaging or your equipment service provider if your unit is affected
- Do not discard the equipment; follow manufacturer instructions for obtaining the correct labeled component
The agency's original wording
Hazard
AIRO pendant replacement kits and upgrade do not possess the "Safe Hand Position Warning" label.
Intended for
All ages
Illnesses reported
None reported
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-1041-2026Want us to check the next one for you?
We read every CPSC, FDA, USDA, and NHTSA notice and email you a plain-English Sunday brief covering your household — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.