FDA-Device2026-01-21Class II
Detachable 10in Pend FRU-1 Pend 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
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-1040-2026Don't want to check this manually?
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