Zenition 70 — Class II medical device recall Z-1583-2025
Ongoing recall by Philips Medical Systems Nederland B.V., reported 2025-04-30, distributed nationwide. Philips has become aware of the potential for unintended radiation exposure with Zenition 70 systems with Vasc
| Recall number | Z-1583-2025 |
|---|---|
| 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 | 2023-07-20 |
| Classified | 2025-04-21 |
| Reported by FDA | 2025-04-30 |
| Distributed | Nationwide (US) |
| Quantity | 12 systems |
Product
Zenition 70. The device is to be used in health care facilities both inside and outside the operating room, sterile as well as non-sterile environment in a variety of procedures.
Reason for recall
Philips has become aware of the potential for unintended radiation exposure with Zenition 70 systems with Vascular Extension option and a Wireless Foot Switch.
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-1583-2025. 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.