Azurion 7 M12 — Class II medical device recall Z-1677-2026
Ongoing recall by PHILIPS MEDICAL SYSTEMS NEDERLAND B.V., reported 2026-04-08, distributed nationwide. Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when usi
| Recall number | Z-1677-2026 |
|---|---|
| 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 | 2026-03-03 |
| Classified | 2026-03-27 |
| Reported by FDA | 2026-04-08 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AF, AR, AT, AU, BD, BE, BG, BH, BO, BR, BS, CA, CH, CL, CN, CO, CR, CY, CZ, DE, DK, DO, DZ, EC, EE, EG, ES, FI, FR, GB, GH, GR, GT, HK, HN, HR, HU, ID, IE, IL, IN, IQ, IR, IS, IT, JO, JP, KE, KR, KW, KY, LB, LK, LT, LV, MA, MT, MX, MY, NG, NI, NL, NO, NP, NZ, OM, PA, PE, PH, PK, PL, PT, PY, QA, RO, RS, SA, SE, SG, SI, SK, SV, TH, TN, TR, TT, TW, UA, UY, VE, VN, ZA |
| UPC / GTIN / UDI-DI | 00884838085251, 00884838099241, 00884838116764 |
| Serial numbers | 100, 1000, 1001, 1003, 1004, 1005, 1007, 1008, 1009, 101, 1010, 1011, 1012, 1013, 1014, 1015, 1016, 1017, 1018, 1019, 102, 1021, 1023, 1024, 1025 and 475 more |
Product
Azurion 7 M12; System Code: (1)722078, (2)722223, (3)722233;
Reason for recall
Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.
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-1677-2026. 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.