Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Philips Azurion Systems R3.0. Includes the following label descriptions and Recalled by PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Due to Nine (9) identified software issues which may result...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. directly.
Affected Products
Philips Azurion Systems R3.0. Includes the following label descriptions and corresponding models: 1. Azurion 3 M12. Model Number: 722229. 2. Azurion 3 M15. Model Number: 722230. 3. Azurion 5 M12. Model Number: 722231. 4. Azurion 5 M20. Model Number: 722232. 5. Azurion 7 B12. Model Number: 722235. 6. Azurion 7 B20. Model Number: 722236. 7. Azurion 7 M12. Model Number: 722233. 8. Azurion 7 M20. Model Number: 722234.
Quantity: 990 units
Why Was This Recalled?
Nine (9) identified software issues which may result in the following: loss of X-ray after Pedal Tap, loss of X-ray after Phase Fault, missing live X-ray on the FlexVision monitor, system continues to restart, AMD triple drive, C-Partition of Suite PC running out of free space, system remains in continuous restart mode after start-up, misalignment of Marker Tool Overlay, longitudinal position error.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. has 154 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report