FDA recall, , Moderate risk
Mobius Imaging AIRO Computed Tomography X-Ray System Pendants
AIRO pendant replacement kits and upgrade do not possess the "Safe Hand Position Warning" label.
Summary by Recall Canary from the FDA notice
What happened
Mobius Imaging, LLC, of Shirley, Massachusetts, recalled the Detachable 10in Pendant Upgrade component and the Detachable 10in Pend FRU-1 Pend component for the AIRO Computed Tomography (CT) X-ray System because the AIRO pendant replacement kits and upgrade do not possess the "Safe Hand Position Warning" label.
The recall began December 4, 2025, and was added to the FDA's Enforcement Report and classified by the FDA on January 9, 2026. Distribution was US Nationwide 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.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
2 products
Affected if its UDI-DI is listed.
A UDI-DI is the device identifier printed with the barcode on the device label.
Detachable 10in Pendant Upgrade component for the AIRO Computed Tomography (CT) X-ray System.
- UDI-DI
- 00869346000200
- 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
- 13904392
Detachable 10in Pend FRU-1 Pend component for the AIRO Computed Tomography (CT) X-ray System.
- UDI-DI
- 00869346000200
- 2232206713
- 2232206723
- 2232206753
- 2232206763
- 2303430363
- 2303430373
- 2303430383
- 2303430393
- 2304034583
- 2304034593
- 2304034603
- 2304034613
- 2304034623
- 2305514123
- 2305514133
- 2305514143
- 2305514153
- 2311019263
- 2315101273
- 2315101283
- 2315101293
- 2315101303
- 2316030903
- 2316030913
- 2316703793
- 2316703803
- 2316703813
- 2316703823
- 2317415513
- 2317415523
- 2317415533
- 2317415543
- 2317415553
- 2317905083
- 2317905093
- 2317905103
- 2317905113
- 2317905123
- 2323513673
- 2323513683
- 2323513693
- 2331419663
- 2331419673
- 2332117403
- 2332117413
- 2332117423
- 2332117433
- 2332117443
- 2333404593
- 2333404603
- 2335506763
- 2335506773
- 2401909563
- 2401909573
- 2401909583
- 2401909593
- 2401909603
- 2401909613
- 2402911603
- 2402911613
- 2402911623
- 2402911633
- 2404302243
- 2404302253
- 2404302263
- 2404302273
- 2409620273
- 2409620283
- 2409620293
- 2409620303
- 2422207853
- 2422207863
- 2422207873
- 2422207883
- 2422207893
- 2422207903
- 2422207913
- 2426303233
- 2426303243
- 2426303253
- 2426303263
- 2426303273
- 2426303283
- 2431210783
- 2431210793
- 2431210803
- 2431210813
- 2431210823
- 2434504553
- 2434504563
- 2434504573
- 2502103553
- 2502103583
- 2502103593
- 2503121733
- 2503121743
- 2503121753
- 2503616113
- 2503616123
- 2503616133
- 2503616213
Recall details
- Company began the recall
- Sold in
US Nationwide distribution in the states of 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.
- Company
- Mobius Imaging, LLCShirley, Massachusetts
- Hazard
- Labeling error
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98099
- Recall numbers
- Z-1040-2026 to Z-1041-2026
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
In FDA's weekly enforcement report
Listed on Recall Canary
