FDA-Device2025-12-17Class II
Azurion R3.0. Model Number 722234. Commercial Name: Azurion 7 M20. INTERVENTIONAL FLUOROSCOPIC XRAY SYSTEM
Philips North America
Hazard
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.
Sold states
U.S.
Affected count
110
Manufactured in
222 Jacobs St, N/A, Cambridge, MA, United States
Products
Azurion R3.0. Model Number 722234. Commercial Name: Azurion 7 M20. INTERVENTIONAL FLUOROSCOPIC XRAY SYSTEM
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0597-2026Don't want to check this manually?
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