PlainRecalls
FDA Devices Moderate Class II Ongoing

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

Reported: October 29, 2025 Initiated: September 29, 2025 #Z-0241-2026

Product Description

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.

Details

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

Frequently Asked Questions

What product was recalled?
Zenition 50; Product Number (REF): 718096; Interventional fluoroscopic x-ray system. Recalled by PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.. Units affected: 29 units.
Why was this product 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.
Which agency issued this recall?
This recall was issued by the FDA Devices on October 29, 2025. Severity: Moderate. Recall number: Z-0241-2026.