Zenition 50 — Class II medical device recall Z-1580-2025
Ongoing recall by Philips North America Llc, reported 2025-04-30. A wireless foot switch pedal may get stuck in the active position when the user releases the pedal, resulting
| Recall number | Z-1580-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | FDA mandated |
| Recalling firm | Philips North America Llc, Cambridge, MA, United States |
| Recall initiated | 2025-02-25 |
| Classified | 2025-04-21 |
| Reported by FDA | 2025-04-30 |
| UPC / GTIN / UDI-DI | 00884838091535 |
Product
Zenition 50. Product Code 718096. The devices are used for radiological guidance and visualization during diagnostic, interventional and surgical procedures on all patients, except neonates (birth to one month), within the limits of the devices.
Reason for recall
A wireless 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-1580-2025. 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.