Detachable 10in Pend FRU-1 Pend component for the AIRO Computed… — Class II medical device recall Z-1040-2026
Ongoing recall by Mobius Imaging, LLC, reported 2026-01-21, distributed nationwide. AIRO pendant replacement kits and upgrade do not possess the "Safe Hand Position Warning" label.
| Recall number | Z-1040-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Mobius Imaging, LLC, Shirley, MA, United States |
| Recall initiated | 2025-12-04 |
| Classified | 2026-01-09 |
| Reported by FDA | 2026-01-21 |
| Distributed | Nationwide (US) |
| Quantity | 101 units |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 00869346000200 |
| Serial numbers | 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 and 76 more |
| Model numbers | MI-76-0237 |
Product
Detachable 10in Pend FRU-1 Pend component for the AIRO Computed Tomography (CT) X-ray System.
Reason for recall
AIRO pendant replacement kits and upgrade do not possess the "Safe Hand Position Warning" label.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1040-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.