FDA Device recall Z-1040-2026
Detachable 10in Pend FRU-1 Pend component for the AIRO Computed Tomography (CT) X-ray System
- FDA Device
- Class II
- ongoing
- Published 2026-01-21
On 2026-01-21 the FDA classified a Class II recall of Detachable 10in Pend FRU-1 Pend component for the AIRO Computed Tomography (CT) X-ray System by Mobius Imaging, citing AIRO pendant replacement kits and upgrade do not possess the "Safe Hand Position Warning" label.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1040-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-12-04 |
| Published | 2026-01-21 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Mobius Imaging |
| Distribution | US |
Product
Detachable 10in Pend FRU-1 Pend 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.
Identifiers
| code_info | Part No. MI-76-0237; UDI: (01) 00869346000200 (11)230920 (21) AIRO-XXXX; Serial No. 2232206713, 2232206723, 2232206753,…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, 2422 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1040-2026%22
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