Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Azurion R3.0. Model Number 722234. Commercial Name: Azurion 7 M20. Recalled by Philips North America Due to Between July 2024 and June 2025, Philips Azurion...
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 North America directly.
Affected Products
Azurion R3.0. Model Number 722234. Commercial Name: Azurion 7 M20. INTERVENTIONAL FLUOROSCOPIC XRAY SYSTEM
Quantity: 110
Why Was This Recalled?
Between July 2024 and June 2025, Philips Azurion R3.0 systems with a FlexArm stand were shipped without the Source-to-Skin Distance (SSD) Spacer. The SSD spacer is necessary to meet the FDA minimum source-skin distance requirement of 38 cm for standard fluoroscopy applications.
Where Was This Sold?
U.S.
About Philips North America
Philips North America has 107 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report