Azurion 5 M20 — Class I medical device recall Z-1156-2025
Ongoing recall by PHILIPS MEDICAL SYSTEMS NEDERLAND B.V., reported 2025-02-26, distributed nationwide. Possibility of the patient falling from the table related to the mattress used on the patient table.
| Recall number | Z-1156-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V., Best, N/A, Netherlands |
| Recall initiated | 2025-01-13 |
| Classified | 2025-02-20 |
| Reported by FDA | 2025-02-26 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AF, AR, AT, AU, BD, BE, BG, BH, BO, BR, 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, JM, 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, TH, TN, TR, TT, TW, UA, UY, VE, VN, ZA |
| UPC / GTIN / UDI-DI | 00884838099234, 00884838116757 |
| Serial numbers | 100, 101, 102, 103, 104, 106, 107, 108, 109, 110, 113, 114, 115, 116, 117, 118, 119, 121, 122, 123, 124, 125, 127, 128, 130 and 315 more |
| Model numbers | 00884838099234, 00884838116757, 722228, 722232, 722281 |
Product
Azurion 5 M20; Catalog numbers: (1) 722228, (2) 722232 (OUS ONLY), (3) 722281 (OUS ONLY).
Reason for recall
Possibility of the patient falling from the table related to the mattress used on the patient table.
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-1156-2025. 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.