The O-arm O2 Imaging System is a mobile x-ray system designed for 2D… — Class II medical device recall Z-2449-2023
Ongoing recall by Medtronic Navigation, Inc.-Littleton, reported 2023-08-30, distributed nationwide. Ground cable installed incorrectly.
| Recall number | Z-2449-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Navigation, Inc.-Littleton, Littleton, MA, United States |
| Recall initiated | 2023-07-25 |
| Classified | 2023-08-24 |
| Reported by FDA | 2023-08-30 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, CH, IE, PL, VN |
| Quantity | 28 units |
| UPC / GTIN / UDI-DI | 00763000074128, 00763000081041, 00763000355555, 00763000496784, 00763000542801, 00763000616434, 00763000616526, 00763000616564 |
| Serial numbers | C2624, C2659, C2660, C2665, C2672, C2708, C2723, C2735, C2760, C2774, C2775, C2779, C2781, C2786, C2798, C2814, C2823, C2841, C2873, C2918, C2968, C3188, C3290, C3322, C3363 and 3 more |
| Model numbers | BI70002000 |
Product
The O-arm O2 Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging for adult and pediatric patients weighing 60 lbs. or greater and having an abdominal thickness greater than 16 cm and is intended to be used where a physician benefits from 2D and 3D information of anatomic structures and objects with high x-ray attenuation such as bony anatomy and metallic objects.
Reason for recall
Ground cable installed incorrectly.
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-2449-2023. 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.