FDA Medical devices recall ·
Detachable 10in Pendant Upgrade component for the AIRO Computed Tomography… recall
- Recall number
- Z-1041-2026
- Date
- (initiated December 4, 2025)
- Company / brand
- Mobius Imaging, LLC
2 Shaker Rd Ste F100, Shirley, MA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 26 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Detachable 10in Pendant Upgrade component for the AIRO Computed Tomography (CT) X-ray System.
Why was it recalled?
AIRO pendant replacement kits and upgrade do not possess the "Safe Hand Position Warning" label.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
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.
States: Alaska Alabama Arizona California Colorado Connecticut District of Columbia Florida Illinois Kentucky Massachusetts Maryland Michigan Minnesota Missouri North Carolina New York Ohio Pennsylvania Rhode Island South Carolina Tennessee Texas Utah Virginia Wisconsin
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1041-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.