FDA-Device2026-01-21Class IIMISBRANDING
Mobius Imaging AIRO CT pendant replacement kits recalled for missing safety warning label
What this means
Mobius Imaging recalled certain replacement pendant components for AIRO CT X-ray systems because they are missing a required "Safe Hand Position Warning" label. The label is important safety information for users of the equipment. No injuries have been reported.
- If you have an AIRO CT system with a pendant replacement kit or upgrade, check the serial number against the FDA recall list
- Contact Mobius Imaging or your equipment service provider for a replacement pendant with the correct warning label
- Do not use the pendant until it has the proper safety warning label
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
101 units
Manufactured in
2 Shaker Rd Ste F100, Shirley, MA, United States
Products
Detachable 10in Pend FRU-1 Pend component for the AIRO Computed Tomography (CT) X-ray System.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1040-2026Want us to check the next one for you?
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