FDA Device recall Z-0241-2026
Zenition 50
- FDA Device
- Class II
- ongoing
- Published 2025-10-29
On 2025-10-29 the FDA classified a Class II recall of Zenition 50 by Philips Medical Systems Nederland B V, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0241-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-09-29 |
| Published | 2025-10-29 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Philips Medical Systems Nederland B V |
| Distribution | MO, TX |
Product
Zenition 50; Product Number (REF): 718096; Interventional fluoroscopic x-ray system
Reason
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.
Identifiers
| code_info | Product Number (REF): 718096; UDI-DI: 00884838091535; All serial numbers; |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0241-2026%22
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