Home / Recalls / Mobius Imaging, LLC / Z-1041-2026

Z-1041-2026 Class II Ongoing

Recalled by Mobius Imaging, LLC — Shirley, MA

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.

Other recalls by Mobius Imaging, LLC

  • Z-1040-2026 Class II — Detachable 10in Pend FRU-1 Pend component for the AIRO Computed Tomography (CT) (December 4, 2025)
  • Z-0957-2023 Class II — MobiCT-32 AIRO Mobile CT Scanner, Cat. No. MobiCT-32, mobile computed tomography (December 7, 2022)
  • Z-0344-2023 Class II — MobiCT-32 AIRO Mobile CT Scanner, Cat. No. MobiCT-32, mobile computed tomography (November 18, 2022)
  • Z-2991-2018 Class II — AIRO Mobile CT System Model # MobiCT-32 (August 1, 2018)
  • Z-0715-2018 Class II — AIRO Mobile CT System, Model Number: MobiCT-32 Product Usage: The AIRO¿ is i (September 26, 2017)
  • Z-1016-2015 Class II — Airo Mobile Intraoperative CT I Airo; Model #: MobiCT-32. Computed Tomography x (December 8, 2014)