Z-1041-2026 Class II Ongoing
FDA device recall Z-1041-2026 was initiated by Mobius Imaging, LLC on December 4, 2025 and is designated Class II. Reason for recall: AIRO pendant replacement kits and upgrade do not possess the "Safe Hand Position Warning" label. The recall status is ongoing. Affected quantity: 26 units.
Recall Details
- Product Type
- Devices
- Report Date
- January 21, 2026
- Initiation Date
- December 4, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 26 units
Product Description
Detachable 10in Pendant Upgrade component for the AIRO Computed Tomography (CT) X-ray System.
Reason for Recall
AIRO pendant replacement kits and upgrade do not possess the "Safe Hand Position Warning" label.
Distribution Pattern
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.
Code Information
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.