Product Wiki · Recalls · U.S. FDA — Device Enforcement

Zenition 50; Product Number (REF): 718096; Interventional fluoroscopic x-ray system — recall Z-0241-2026

U.S. FDA — Device Enforcement · Netherlands · 2025-09-29 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0241-2026
Date of alert
2025-09-29
Country / jurisdiction
Netherlands
Risk level
Class II
Risk type
recall
Brand
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
00884838091535
Reported risk: 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.
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.