Azurion R3 — Class II medical device recall Z-0597-2026
Ongoing recall by Philips North America, reported 2025-12-17. Between July 2024 and June 2025, Philips Azurion R3.0 systems with a FlexArm stand were shipped without the So
| Recall number | Z-0597-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | FDA mandated |
| Recalling firm | Philips North America, Cambridge, MA, United States |
| Recall initiated | 2025-10-27 |
| Classified | 2025-12-09 |
| Reported by FDA | 2025-12-17 |
| Quantity | 110 |
| Model numbers | 722234 |
Product
Azurion R3.0. Model Number 722234. Commercial Name: Azurion 7 M20. INTERVENTIONAL FLUOROSCOPIC XRAY SYSTEM
Reason for recall
Between July 2024 and June 2025, Philips Azurion R3.0 systems with a FlexArm stand were shipped without the Source-to-Skin Distance (SSD) Spacer. The SSD spacer is necessary to meet the FDA minimum source-skin distance requirement of 38 cm for standard fluoroscopy applications.
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-0597-2026. 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.