Mobius Imaging, LLC recalls Detachable 10in Pendant Upgrade component for the AIRO Computed Tomography (CT) X-ray System.
- Recall date
- December 4, 2025
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-1041-2026
- FDA classification
- Class II
- Brand / firm
- Mobius Imaging, LLC
- Sold / distributed
- 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.
Why it was recalled
AIRO pendant replacement kits and upgrade do not possess the "Safe Hand Position Warning" label.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Detachable 10in Pendant Upgrade component for the AIRO Computed Tomography (CT) X-ray System.
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