Philips Azurion Interventional Fluoroscopic X-ray System with Azurion… — Class II medical device recall Z-0471-2022
Terminated recall by Philips North America Llc, reported 2022-01-19, distributed nationwide. (1)Start-up problem: Intermittently at start-up of the system, the communication of the control unit that mana
| Recall number | Z-0471-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips North America Llc, Cambridge, MA, United States |
| Recall initiated | 2021-11-12 |
| Classified | 2022-01-10 |
| Reported by FDA | 2022-01-19 |
| Terminated | 2024-02-05 |
| Distributed | Nationwide (US) |
| Countries outside the US | DE, FR, GB, JP, PL |
| UPC / GTIN / UDI-DI | 00884838085251, 00884838085367, 00884838099203, 00884838099234, 00884838099258, 00884838099265, 00884838099272 |
| Model numbers | 722068, 722078, 722221, 722224, 722225, 722226, 722228 |
Product
Philips Azurion Interventional Fluoroscopic X-ray System with Azurion R2.2 with LUC configuration start-up issue; Azurion R2.2 emergency stop recovery issue Model Numbers: 722221, 722228, 722225, 722068, 722226, 722078, 722224
Reason for recall
(1)Start-up problem: Intermittently at start-up of the system, the communication of the control unit that manages the movement of the stand is not established; (2) Emergency stop recovery problem-warm restart is not executed correctly and movement functionality is not available
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-0471-2022. 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.