Azurion R3.0. Model Number 722234. Commercial Name: Azurion 7 M20. INTERVENTIONAL FLUOROSCOPIC XRAY SYSTEM
Reported: December 17, 2025 Initiated: October 27, 2025 #Z-0597-2026
Product Description
Azurion R3.0. Model Number 722234. Commercial Name: Azurion 7 M20. INTERVENTIONAL FLUOROSCOPIC XRAY SYSTEM
Reason for Recall
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.
Details
- Recalling Firm
- Philips North America
- Units Affected
- 110
- Distribution
- U.S.
- Location
- Cambridge, MA
Frequently Asked Questions
What product was recalled? ▼
Azurion R3.0. Model Number 722234. Commercial Name: Azurion 7 M20. INTERVENTIONAL FLUOROSCOPIC XRAY SYSTEM. Recalled by Philips North America. Units affected: 110.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 17, 2025. Severity: Moderate. Recall number: Z-0597-2026.
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