Device product
Zenition 50; Product Number (REF): 718096; Interventional fluoroscopic x-ray system
Z-0241-2026
Product summary
- Event
- Event 97682
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 29 units
- Official record key
device-enforcement:Z-0241-2026
Official wording
Reason: 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.
Code information: Product Number (REF): 718096; UDI-DI: 00884838091535; All serial numbers;
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.
Derived failure modes
-
Unknown
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.