Azurion R3.0. Model Number 722234. Commercial Name: Azurion 7 M20. INTERVENTIONAL FLUOROSCOPIC XRAY SYSTEM
FDA device recall Z-0597-2026 · posted 2025-12-09 · Open, Classified
Recall details
- Recalling firm
- Philips North America
- 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.
- Action taken
- Philips will send a customer notification to the users of the affected systems to alert them of the issue and provide the actions that should be taken to prevent risks to patients. Philips will contact customers to schedule a time for a Philips Field Service Engineer (FSE) to visit their site and install the SSD spacer to resolve the issue.
- Root cause
- Radiation Control for Health and Safety Act
- Status
- Open, Classified
- Product code
- JAA
- Quantity affected
- 110
- Distribution
- U.S.
- Date initiated
- 2025-10-27
- Date posted
- 2025-12-09
- Location
- Cambridge, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Azurion R2.1 (K200917) | Philips Medical Systems Nederland B.V. | 2020-05-01 |