Z-0241-2026 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- October 29, 2025
- Initiation Date
- September 29, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 29 units
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.
Distribution Pattern
Distribution US states of MO and TX; Belgium, Canada, Fiji, Germany, India, Malaysia, Mexico, Morocco, South Africa, South Korea, Thailand, United Kingdom, and Uzbekistan.
Code Information
Product Number (REF): 718096; UDI-DI: 00884838091535; All serial numbers;