FDA-Device2025-10-29Class IIPROCESSING DEFECT
Philips Zenition 50 X-Ray System Recalled for Image Intensifier Control Board Corrosion
Philips Zenition 50 X-ray system recalled for imaging failure risk
Philips Zenition 50 interventional X-ray systems may experience loss of imaging ability or degraded image quality over time due to corrosion of an internal control board. The issue affects 29 units distributed across multiple countries including the United States.
- If you operate or maintain a Zenition 50 system, contact Philips Medical Systems immediately for guidance on inspection and potential repair or replacement of the affected control board.
- Do not rely on the system for clinical imaging until the corrosion issue has been assessed and corrected.
Hazard
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.
Sold states
Distribution US states of MO and TX; Belgium, Canada, Fiji, Germany, India, Malaysia, Mexico, Morocco, South Africa, South Korea, Thailand, United Kingdom, and Uzbekistan.
Affected count
29 units
Manufactured in
Veenpluis 4-6, Best, Netherlands
Products
Zenition 50; Product Number (REF): 718096; Interventional fluoroscopic x-ray system
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0241-2026More PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls
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