Mobius Imaging, LLC: Detachable 10in Pendant Upgrade component for the AIRO Computed Tomography (CT) X-ray System.
Read the official notice at FDA (device) →
The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.
- Company / brand
- Mobius Imaging, LLC
- Product
- Detachable 10in Pendant Upgrade component for the AIRO Computed Tomography (CT) X-ray System.
- Reason / hazard
- AIRO pendant replacement kits and upgrade do not possess the "Safe Hand Position Warning" label.
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- 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.
- Recall initiated
- 2025-12-04
- Code info
- 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.
- Product quantity
- 26 units
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Shirley
- State
- MA
- Country
- United States
- Event id
- 98099
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