Philips Azurion systems not configured with an optional auxiliary pan… — Class II medical device recall Z-2225-2026
Ongoing recall by PHILIPS MEDICAL SYSTEMS NEDERLAND B.V., reported 2026-05-27, distributed nationwide. Potential safety issue with Philips Azurion systems, where longitudinal and transverse table movements may be
| Recall number | Z-2225-2026 |
|---|---|
| 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 | 2026-04-28 |
| Classified | 2026-05-21 |
| Reported by FDA | 2026-05-27 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AT, AU, BD, BE, BO, BR, CA, CL, DZ, EE, GR, HK, HN, ID, IQ, IS, JP, LK, MT, MY, NP, NZ, PH, QA, SG, SV, VN, ZA |
| Quantity | 5,537 units |
| UPC / GTIN / UDI-DI | 00884838085251, 00884838085268, 00884838085275, 00884838085282, 00884838085350, 00884838085367, 00884838099210, 00884838099227, 00884838099234, 00884838099241, 00884838099258, 00884838099265, 00884838099272, 00884838103276, 00884838110564, 00884838110571, 00884838116726, 00884838116733, 00884838116740, 00884838116757, 00884838116764, 00884838116771, 00884838116788, 00884838116801 |
| Model numbers | 722063, 722064, 722067, 722068, 722078, 722079, 722222, 722223, 722224, 722225, 722226, 722227, 722228, 722229, 722230, 722231, 722232, 722233, 722234, 722235, 722236, 722280, 722281, 722282 |
Product
Philips Azurion systems not configured with an optional auxiliary pan handle. Includes the below product descriptions and corresponding model numbers. 1. Azurion 3 M12; Model Numbers: 722063, 722229. 2. Azurion 3 M15; Model Numbers: 722222, 722064, 722280, 722230. 3. Azurion 5 M12; Model Numbers: 722227, 722231. 4. Azurion 5 M20; Model Numbers: 722228, 722232, 722281. 5. Azurion 7 B12; Model Numbers: 722067, 722225, 722235. 6. Azurion 7 B20; Model Numbers: 722068, 722226, 722236. 7. Azurion 7 M12; Model Numbers: 722078, 722223, 722233. 8. Azurion 7 M20; Model Numbers: 722079, 722224, 722234, 722282.
Reason for recall
Potential safety issue with Philips Azurion systems, where longitudinal and transverse table movements may be impacted due to mechanical wear of the Float Tabletop control on the control module.
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-2225-2026. 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.