Philips Azurion Interventional Fluoroscopic X-ray Systems — Class II medical device recall Z-1145-2024
Ongoing recall by PHILIPS MEDICAL SYSTEMS NEDERLAND B.V., reported 2024-02-28, distributed nationwide. Framegrabber card may not perform as intended. Monitor may show no viewports, or show one or more viewports ma
| Recall number | Z-1145-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V., Best, N/A, Netherlands |
| Recall initiated | 2024-01-02 |
| Classified | 2024-02-16 |
| Reported by FDA | 2024-02-28 |
| Distributed | Nationwide (US) |
| UPC / GTIN / UDI-DI | 00884838059191, 00884838059207, 00884838059221, 00884838059290, 00884838064775, 00884838085251, 00884838085268, 00884838085350, 00884838085367, 00884838086777, 00884838099241 |
| Serial numbers | 101, 1018, 103, 104, 1042, 1063, 107, 110, 111, 113, 114, 117, 121, 1211, 125, 1267, 1274, 130, 131, 133, 136, 137, 1380, 1382, 141 and 279 more |
Product
Philips Azurion Interventional Fluoroscopic X-ray Systems, specifically the Disk Bay of the PC component of the affected system. Affected PCs: FlexViewing PC Azurion Model Name - Model Number: Azurion 7 B12 722067; Azurion 7 B20 722068; Azurion 7 M12 722078 722223; Azurion 7 M20 722079;
Reason for recall
Framegrabber card may not perform as intended. Monitor may show no viewports, or show one or more viewports may show no image, a distorted image, or a frozen image. Switching between viewports on the monitor may not be possible. Issue may result in delay of 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-1145-2024. 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.