Philips Azurion 5M20 — Class II medical device recall Z-2287-2026
Ongoing recall by PHILIPS MEDICAL SYSTEMS NEDERLAND B.V., reported 2026-06-10, distributed nationwide. During the device phase of Roadmap Pro, a user may experience a dark image that is not clinically usable. The
| Recall number | Z-2287-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Recalling firm | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V., Best, Netherlands |
| Recall initiated | 2023-12-07 |
| Classified | 2026-06-01 |
| Reported by FDA | 2026-06-10 |
| Distributed | Nationwide (US) |
| Quantity | 51 units |
| UPC / GTIN / UDI-DI | 00884838099234 |
| Model numbers | 722228 |
Product
Philips Azurion 5M20, Model Numbers: 722228 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the Roadmap Pro Software key
Reason for recall
During the device phase of Roadmap Pro, a user may experience a dark image that is not clinically usable. The dark image may result after the user performs a pedal tap (shortly touching the footswitch pedal without generating an Xray image). The pedal tap may cause a dark image with the next fluoroscopy run.
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-2287-2026. 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.