Zenition recallZ-0241-2026 · Philips Medical Systems Nederland B.V. · initiated Sep 29, 2025
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Philips Medical Systems Nederland B.V. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
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.
FDA root cause category: Process control
What the company is doing
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.
Recall details
- Recall number
- Z-0241-2026
- Status
- Open, Classified
- Initiated by the company
- Sep 29, 2025
- Posted by the FDA
- Oct 23, 2025
- Recalling firm
- Philips Medical Systems Nederland B.V.
- Quantity
- 29 units
- Product code
- OWB
- FDA submissions
- K183101
- 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.
Product description
Zenition 50; Product Number (REF): 718096; Interventional fluoroscopic x-ray system
Code information (models, lots, serial numbers)
Product Number (REF): 718096; UDI-DI: 00884838091535; All serial numbers;
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Zenition Zenition 50Philips Medical Systems Nederland B.V. · Image-Intensified Fluoroscopic X-Ray System, Mobile3 recalls21 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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