Philips Azurion system — Class II medical device recall Z-0835-2024
Ongoing recall by PHILIPS MEDICAL SYSTEMS NEDERLAND B.V., reported 2024-02-07, distributed nationwide. System may exhibit a loss of imaging functionality and data due to an issue which can cause the system to cont
| Recall number | Z-0835-2024 |
|---|---|
| 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 | 2023-12-12 |
| Classified | 2024-01-26 |
| Reported by FDA | 2024-02-07 |
| Distributed | Nationwide (US) |
| UPC / GTIN / UDI-DI | 00884838059184, 00884838059191, 00884838059207, 00884838059221, 00884838059290, 00884838064775, 00884838085251, 00884838085268, 00884838085275, 00884838085282, 00884838085350, 00884838085367, 00884838086777, 00884838099203, 00884838099210, 00884838099227, 00884838099234, 00884838099241, 00884838099258, 00884838099265, 00884838099272, 00884838101883, 00884838101890, 00884838103276 |
Product
Philips Azurion system, Interventional fluoroscopic x-ray system. System Product Name - Model Numbers Azurion 3M12 -722063, 722221; Azurion 3M15 - 722064, 722222; Azurion 5M12 - 722227; Azurion 5M20 - 722228; Azurion 7B12/12 - 722067, 722225; Azurion 7B20/15 - 722068, 722226; Azurion 7M12 - 722078, 722223; Azurion 7M20 - 722079, 722224; Azurion 3 M15 (China) - 722280;
Reason for recall
System may exhibit a loss of imaging functionality and data due to an issue which can cause the system to continuously restart. If the issue occurs during a procedure, there may be a delay and/or abortion of the procedure.
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-0835-2024. 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.