Azurion — Class II medical device recall Z-2403-2023
Ongoing recall by Philips Medical Systems Nederland B.V., reported 2023-09-13, distributed nationwide. A foot switch pedal may get stuck in the active position when the user releases the pedal, resulting in the em
| Recall number | Z-2403-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | FDA mandated |
| Recalling firm | Philips Medical Systems Nederland B.V., Eindhoven, N/A, Netherlands |
| Recall initiated | 2023-07-19 |
| Classified | 2023-09-07 |
| Reported by FDA | 2023-09-13 |
| Distributed | Nationwide (US) |
| Quantity | 5,432 systems |
Product
Azurion
Reason for recall
A foot switch pedal may get stuck in the active position when the user releases the pedal, resulting in the emission of unintended radiation
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-2403-2023. 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.