Recall Z-0241-2026— PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Class II · Ongoing
Class II FDA medical device recall by PHILIPS MEDICAL SYSTEMS NEDERLAND B.V., initiated 2025-09-29. It names one FDA 510(k) clearance: K183101. Product: 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..
- Recalling firm
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-09-29
- Firm location
- Best, Netherlands
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.