FDA Enforcement
Class II
Ongoing
Zenition 50; Product Number (REF): 718096; Interventional fluoroscopic x-ray system
Recall: Z-0241-2026
·
Reported October 29, 2025
Enforcement
- Recall Number
- Z-0241-2026
- Event ID
- 97682
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- October 29, 2025
- Initiation Date
- September 29, 2025
- Classification Date
- October 23, 2025
- Address
- Veenpluis 4-6, Best, N/A, Netherlands
Description
Zenition 50; Product Number (REF): 718096; Interventional fluoroscopic x-ray system
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 Info
Product Number (REF): 718096; UDI-DI: 00884838091535; All serial numbers;
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.
Quantity
29 units