FDA recall Z-0241-2026

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Class II · device

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.

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.

Key facts

Status
Ongoing
Initiation date
2025-09-29
Report date
2025-10-29
Voluntary/Mandated
Voluntary: Firm initiated
Location
Best, Netherlands

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0241-2026