—#216352

Product

Zenition 50; Product Number (REF): 718096; Interventional fluoroscopic x-ray system

FDA product code: OWB — Interventional Fluoroscopic X-Ray System
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K183101
Affected lot / code info: Product Number (REF): 718096; UDI-DI: 00884838091535; All serial numbers;

Why it was recalled

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.

Root cause (FDA determination)

Process control

Action the firm took

On September 29, 2025 URGENT MEDICAL DEVICE CORRECTION letters were sent to customers. Actions to be taken: 1. Circulate this notice to all users and follow the instructions in the letter. 2. Affected systems may continue to be used in accordance with their intended use and Instructions for Use (IFU). 3. Ensure the letter is in a place likely to be seen/viewed. 4. In case the affected system has been transferred to another organization, please send a copy of this Urgent Medical Device Correction letter to that organization and inform Philips about this transfer through your local Philips representative. 5. If you experience the issue described in this letter, please report it to your local Philips representative. Actions by Philips: Starting in October 2025, Philips will replace the 11W control board of the affected Zenition 50 systems. Your local Philips representative will contact you to schedule a visit to perform this activity in your system.

Recalling firm

Firm: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands

Distribution

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.

Timeline

Recall initiated: 2025-09-29
Posted by FDA: 2025-10-23
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #216352. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.