Reported Dec 17, 2025 · Ongoing
Azurion R3.0. Model Number 722234. Commercial Name: Azurion 7 M20. INTERVENTIONAL FLUOROSCOPIC XRAY SYSTEM
Philips North America
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Philips North America · 222 Jacobs St · Cambridge, MA · 02141-2296
Is this the product you have?
- Azurion R3.0. Model Number 722234
- Commercial NameAzurion 7 M20. INTERVENTIONAL FLUOROSCOPIC XRAY SYSTEM
- Lot codes and dates
- Model Number 722234 Commercial NameAzurion 7
- M20 How to identifyPhilips Reference C&R 2025-IGT-BST-016
- Amount recalled
- 110
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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