Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Azurion lnterventional Fluoroscopic X-ray System Recalled by Philips Medical Systems Nederlands Due to Philips has discovered through customer complaints and internal...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Philips Medical Systems Nederlands directly.
Affected Products
Azurion lnterventional Fluoroscopic X-ray System, with software version 1.2
Quantity: 229
Why Was This Recalled?
Philips has discovered through customer complaints and internal testing an intermittent electronic product defect in accordance with 21 CFR 1003.2(b)(1). When performing Cine runs, the Azurion's automatic exposure control software may set technique factors that result in radiation emissions too low to obtain useful diagnostic images.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Philips Medical Systems Nederlands
Philips Medical Systems Nederlands has 79 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report