FDA Device recall Z-1041-2026
Detachable 10in Pendant Upgrade 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 Pendant Upgrade 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-1041-2026 |
| 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 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.
Identifiers
| code_info | Part No. MI-70-0128; UDI: (01) 00869346000200 (11)230920 (21) AIRO-XXXX; Serial No. 2232206183, 2232206193, 2232206203,…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. |
|---|
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-1041-2026%22
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