Detachable 10in Pend FRU-1 Pend component for the AIRO recall
Detachable 10in Pend FRU-1 Pend component for the AIRO Computed Tomography (CT) X-ray System.
Why was Detachable 10in Pend FRU-1 Pend component for the AIRO recalled?
AIRO pendant replacement kits and upgrade do not possess the "Safe Hand Position Warning" label.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Part No. MI-76-0237; UDI: (01) 00869346000200 (11)230920 (21) AIRO-XXXX; Serial No. 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.
- Product
- Detachable 10in Pend FRU-1 Pend component for the AIRO Computed Tomography (CT) X-ray System.
- Recalling firm
- Mobius Imaging, LLC
- Quantity
- 101 units
- 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.
- Recall date
- January 21, 2026
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)