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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Diagnostic Equipment

AIRO CT System Pendant Components Recalled for Missing Safety Labels

Agency Publication Date: January 9, 2026
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Summary

Mobius Imaging, LLC has recalled 127 AIRO Computed Tomography (CT) X-ray System pendant components, including replacement kits and upgrades. These devices are missing the "Safe Hand Position Warning" label, which is necessary to inform users of proper handling. Without this warning, operators may place their hands in hazardous areas during device movement, which could lead to physical injury.

Risk

The absence of safety labels increases the risk of crushing or pinching injuries to the operator's hands or fingers if they are placed in unsafe positions while moving the heavy imaging equipment.

What You Should Do

  1. This recall affects detachable 10-inch pendant replacement kits (Part MI-76-0237) and upgrades (Part MI-70-0128) used with the AIRO Computed Tomography (CT) X-ray System.
  2. Check the part number and serial number on the device label to determine if your component is part of this recall. See the Affected Products section below for the full list of affected codes.
  3. Stop using the recalled product. Contact the manufacturer or your distributor to arrange return, replacement, or correction.
  4. For additional information, contact the FDA at 1-888-463-6332.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: Detachable 10in Pend FRU-1 Pend component for the AIRO Computed Tomography (CT) X-ray System
Model / REF:
MI-76-0237
Serial Numbers (101):
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
UDI:
00869346000200

Recall #: Z-1040-2026; Component for AIRO Computed Tomography (CT) X-ray System.

Product: Detachable 10in Pendant Upgrade component for the AIRO Computed Tomography (CT) X-ray System
Model / REF:
MI-70-0128
Serial Numbers:
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
UDI:
00869346000200

Recall #: Z-1041-2026; Upgrade component for AIRO Computed Tomography (CT) X-ray System.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 98099
Status: Active
Manufacturer: Mobius Imaging, LLC
Sold By: Mobius Imaging, LLC authorized distributors
Manufactured In: United States
Units Affected: 2 products (101 units; 26 units)
Distributed To: 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

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.