FDAFDA · Food and drugs·Recall number Z-0241-2026
Zenition 50; Product Number (REF): 718096; Interventional fluoroscopic x-ray system
Published October 29, 2025 · Recall initiated: September 29, 2025
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- Distributor
- Distribution US states of MO and TX; Belgium, Canada, Fiji, Germany, India, Malaysia, Mexico, Morocco, South Africa, South Korea, Thailand, United Kingdom, and Uzbekistan.
- Lot
- Product Number (REF): 718096; UDI-DI: 00884838091535; All serial numbers;
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Netherlands
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