FDA Enforcement
Class II
Ongoing
Detachable 10in Pendant Upgrade component for the AIRO Computed Tomography (CT) X-ray System.
Recall: Z-1041-2026
·
Reported January 21, 2026
Enforcement
- Recall Number
- Z-1041-2026
- Event ID
- 98099
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Mobius Imaging, LLC
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- January 21, 2026
- Initiation Date
- December 4, 2025
- Classification Date
- January 9, 2026
- Address
- 2 Shaker Rd Ste F100, Shirley, MA, 01464-2535, United States
Description
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.
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.
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.
Quantity
26 units