Azurion 7 M20 — Class II medical device recall Z-2134-2025
Ongoing recall by PHILIPS MEDICAL SYSTEMS NEDERLAND B.V., reported 2025-07-30, distributed nationwide. Potential for bolts connecting the gearbox to the mounting flange of the C-arm to become loose.
| Recall number | Z-2134-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V., Best, N/A, Netherlands |
| Recall initiated | 2025-06-04 |
| Classified | 2025-07-18 |
| Reported by FDA | 2025-07-30 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AU, CA, CL, DE, DO, EG, FR, GB, IT, JP, KR, MX, NL, NZ, OM, TH, VN |
| Quantity | 78 units |
| UPC / GTIN / UDI-DI | 00884838085268 |
| Serial numbers | 321, 370, 525, 549, 567, 584, 587, 613, 631, 658, 670, 687, 688, 693, 707, 708, 743, 750, 759, 767, 768, 774, 775, 777, 785 and 47 more |
| Model numbers | 722079 |
Product
Azurion 7 M20. Fluoroscopic X-Ray System.
Reason for recall
Potential for bolts connecting the gearbox to the mounting flange of the C-arm to become loose.
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-2134-2025. 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.