Zenition 50; Product Number (REF): 718096; Interventional fluoroscopic x-ray system
FDA Recall Z-0241-2026 · Posted 2025-10-23
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Recalling FirmPHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Recall StatusOpen, Classified
Product CodeOWB
Date Initiated2025-09-29
Product Quantity29 units
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.
Firm Action
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.
Root Cause
Process control
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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