Philips Azurion 7 M20 X-ray system recalled for missing radiation safety spacer
Between July 2024 and June 2025, some Philips Azurion R3.0 fluoroscopic X-ray systems (model 722234) were shipped without a required safety spacer. This spacer ensures the X-ray tube maintains a safe distance from patients during standard fluoroscopy procedures, as required by FDA regulations.
From the FDA notice · Read the official notice ↗ · All Philips recalls
What to do
- If you operate a Philips Azurion 7 M20 system, contact Philips to verify whether your unit has the Source-to-Skin Distance (SSD) Spacer installed
- Reference Philips notice C&R 2025-IGT-BST-016 when contacting Philips
- Do not use the system for standard fluoroscopy if the spacer is missing until it is installed
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- Azurion R3.0. Model Number 722234. Commercial Name: Azurion 7 M20. INTERVENTIONAL FLUOROSCOPIC XRAY SYSTEM
- Sold in
- Nationwide
- Made for
- All ages (0 months and older)
Details
- Units affected
- 110
- Illnesses reported
- None reported
- Manufactured in
- 222 Jacobs St, N/A, Cambridge, MA, United States
- Classification
- Class II
- Recall number
- Z-0597-2026
In the FDA's words
- Description
- Azurion R3.0. Model Number 722234. Commercial Name: Azurion 7 M20. INTERVENTIONAL FLUOROSCOPIC XRAY SYSTEM 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. Model Number 722234 Commercial Name: Azurion 7 M20 How to identify: Philips Reference C&R 2025-IGT-BST-016 Distribution: U.S. Affected quantity: 110
- 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.
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