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Recall Observatory FDA recall evidence

Device product

Detachable 10in Pendant Upgrade component for the AIRO Computed Tomography (CT) X-ray System.

Z-1041-2026

December 04, 2025

Class II

Product summary

Firm
Mobius Imaging, LLC
Event
Event 98099
Status
Ongoing
Classification
Class II
Quantity
26 units
Official record key
device-enforcement:Z-1041-2026

Official wording

Reason: AIRO pendant replacement kits and upgrade do not possess the "Safe Hand Position Warning" label.

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.

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    AIRO pendant replacement kits and upgrade do not possess the "Safe Hand Position Warning" label.