Detachable 10in Pendant Upgrade component for the AIRO Computed Tomography recall (Mobius Imaging, LLC)

Medical deviceClass IIOngoing

Summary: Mobius Imaging, LLC is recalling Detachable 10in Pendant Upgrade component for the AIRO Computed Tomography (CT) X-ray System.. Reason: AIRO pendant replacement kits and upgrade do not possess the "Safe Hand Position Warning" label.

What is being recalled

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

Why

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

How serious is it

Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.

Where it was sold

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 named: 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)

How to tell if yours is affected

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.

What to do

Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.

Recall facts

More recalls from Mobius Imaging, LLC · all medical device recalls · recalls from December 2025

Official FDA record