Philips Azurion Systems R3 — Class II medical device recall Z-1079-2026
Ongoing recall by PHILIPS MEDICAL SYSTEMS NEDERLAND B.V., reported 2026-01-21, distributed nationwide. Nine (9) identified software issues which may result in the following: loss of X-ray after Pedal Tap, loss of
| Recall number | Z-1079-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V., Best, Netherlands |
| Recall initiated | 2025-12-08 |
| Classified | 2026-01-14 |
| Reported by FDA | 2026-01-21 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AT, AU, BD, BE, BG, BR, CA, CH, CL, CO, CZ, DE, DK, DZ, EC, EE, EG, ES, FI, FR, GB, GR, HK, HN, HR, ID, IL, IN, IQ, IT, JP, KR, LB, LK, LT, MA, MY, NI, NL, NO, NP, NZ, OM, PH, PL, PT, RO, RS, SA, SE, SG, SV, TH, TN, TW, UA, VN, ZA |
| Quantity | 990 units |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 00884838116726, 00884838116733, 00884838116740, 00884838116757, 00884838116764, 00884838116771, 00884838116788, 00884838116801 |
| Model numbers | 722229, 722230, 722231, 722232, 722233, 722234, 722235, 722236 |
Product
Philips Azurion Systems R3.0. Includes the following label descriptions and corresponding models: 1. Azurion 3 M12. Model Number: 722229. 2. Azurion 3 M15. Model Number: 722230. 3. Azurion 5 M12. Model Number: 722231. 4. Azurion 5 M20. Model Number: 722232. 5. Azurion 7 B12. Model Number: 722235. 6. Azurion 7 B20. Model Number: 722236. 7. Azurion 7 M12. Model Number: 722233. 8. Azurion 7 M20. Model Number: 722234.
Reason for recall
Nine (9) identified software issues which may result in the following: loss of X-ray after Pedal Tap, loss of X-ray after Phase Fault, missing live X-ray on the FlexVision monitor, system continues to restart, AMD triple drive, C-Partition of Suite PC running out of free space, system remains in continuous restart mode after start-up, misalignment of Marker Tool Overlay, longitudinal position error.
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-1079-2026. 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.