PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Zenition 50; Product Number (REF): 718096; Interventional fluoroscopic x-ray system

Recall date

September 29, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0241-2026

FDA classification

Class II

Brand / firm

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Sold / distributed

Distribution US states of MO and TX; Belgium, Canada, Fiji, Germany, India, Malaysia, Mexico, Morocco, South Africa, South Korea, Thailand, United Kingdom, and Uzbekistan.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Zenition 50; Product Number (REF): 718096; Interventional fluoroscopic x-ray system