Zenition 50 — Class II medical device recall Z-0241-2026
Ongoing recall by PHILIPS MEDICAL SYSTEMS NEDERLAND B.V., reported 2025-10-29, distributed in MO, TX. Over time some systems may experience loss of imaging functionality and/or poor image quality due to potential
| Recall number | Z-0241-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V., Best, Netherlands |
| Recall initiated | 2025-09-29 |
| Classified | 2025-10-23 |
| Reported by FDA | 2025-10-29 |
| Distributed | MO, TX |
| Countries outside the US | BE, CA, DE, GB, IN, KR, MA, MX, MY, TH, ZA |
| Quantity | 29 units |
| UPC / GTIN / UDI-DI | 00884838091535 |
| Model numbers | 00884838091535, 718096 |
Product
Zenition 50; Product Number (REF): 718096; Interventional fluoroscopic x-ray system
Reason for recall
Over time some systems may experience loss of imaging functionality and/or poor image quality due to potential corrosion of the Image Intensifier Television (IITV) control board.
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-0241-2026. 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.