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FDA-Device2026-01-21Class IIMISBRANDING

Mobius Imaging AIRO CT pendant upgrade lacks safety warning label

Mobius Imaging
FALSE CLAIMSNationwide distribution

Check your AIRO CT pendant for safety label

Mobius Imaging's detachable 10-inch pendant upgrade kits for AIRO Computed Tomography systems are missing a required "Safe Hand Position Warning" label. This label is important for safe operation of the equipment. The affected units were distributed nationwide.

  • If you operate an AIRO CT system with a pendant upgrade, check the serial number against the list provided by the FDA
  • Contact Mobius Imaging or your equipment service provider if your unit is affected
  • Do not discard the equipment; follow manufacturer instructions for obtaining the correct labeled component
Hazard

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

Sold states
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.
Affected count
26 units
Manufactured in
2 Shaker Rd Ste F100, Shirley, MA, United States
Products
Detachable 10in Pendant Upgrade component for the AIRO Computed Tomography (CT) X-ray System.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1041-2026

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