Mobius Imaging, LLC recalls Detachable 10in Pendant Upgrade component for the AIRO Computed Tomography
- Recalling company
- Mobius Imaging, LLC
- Product
- Detachable 10in Pendant Upgrade component for the AIRO Computed Tomography (CT) X-ray System.
- Reason
- AIRO pendant replacement kits and upgrade do not possess the "Safe Hand Position Warning" label.
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Dec 4, 2025
- Reported
- Jan 21, 2026
- Distribution
- 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.
- Status
- Ongoing
- Quantity
- 26 units
- Lot / codes
- Part No. MI-70-0128; UDI: (01) 00869346000200 (11)230920 (21) AIRO-XXXX; Serial No. 2232206183, 2232206193, 2232206203, 2232206213, 2232206223, 2232206233, 2235522143, 2235522153, 2235522163, 2236339153, 2236339163, 2236339173, 2236339183, 2303429483, 2303429503, 2313925663, 2313925673, 2316030773, 2316030783, 2316703503, 2316703523, 2317415473, 2320006923, 2320006933, 2323513413, 70-0128-13904392.
- Company location
- Shirley, MA
- Recall type
- Voluntary: Firm initiated
- Recall number
- Z-1041-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-1041-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.