Philips Azurion System with software versions: R2.2.O, R2.2.1, R2.2.3, R2.2.5 and R2.2.6. Model...
FDA Device Recall #Z-1647-2023 — Class II — March 21, 2023
Recall Summary
| Recall Number | Z-1647-2023 |
| Classification | Class II — Moderate risk |
| Date Initiated | March 21, 2023 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Location | Best, N/A |
| Product Type | Devices |
| Quantity | USA: 1063 R.O.W. 2136 |
Product Description
Philips Azurion System with software versions: R2.2.O, R2.2.1, R2.2.3, R2.2.5 and R2.2.6. Models/Model Number: (1) Azurion 3M12: 722063, 722221; (2) Azurion 3M15: 722064, 722222; (3) Azurion SM12: 722227; (4) Azurion SM20: 722228; (5) Azurion 7B12/12: 722067, 722225; (6) Azurion 7820/15: 722068, 722226; (7) Azurion 7M12: 722078, 722223; (8) Azurion 7M20 : 722079, 722224
Reason for Recall
Potential Loss of X-ray-When the full disk capacity is reached, X-Ray functionality will cease to be available there will be a sudden interruption of the procedure
Distribution Pattern
Nationwide Foreign: Algeria Argentina Armenia Australia Austria Bahrain Bangladesh Belarus Belgium Bolivia Brazil Bulgaria Cambodia Chile China Colombia Costa Rica C¿te D'Ivoire Croatia Cyprus Czech Republic Denmark Dominican Rep Ecuador Egypt Estonia Finland France French Polynesia Germany Greece Hong Kong Hungary India Indonesia Iran Iraq Ireland Israel Italy Japan Jordan Kazakhstan Kenya Korea, Republic of Kosovo Kuwait Latvia Lebanon Lithuania Macao Macedonia Malaysia Mexico Morocco Myanmar Nepal Netherlands New Zealand Nicaragua Nigeria Norway Oman Pakistan Palestine Palestine, State of Panama Peru Philippines Poland Portugal Puerto Rico Qatar Romania Russian Federation Saudi Arabia Senegal Serbia Singapore Slovakia Slovenia South Africa South Korea Spain Sri Lanka Sweden Switzerland Taiwan Thailand Tunisia Turkey Turkmenistan Ukraine United Kingdom Utd.Arab.Emir. Uzbekistan Vietnam Yemen
Lot / Code Information
UDI-DI: System product name Model number UDI (1)Azurion 3M12: 722063 (01)00884838085275(21) 722221 (01)00884838099203(21); (2) Azurion 3M15: 722064 (01)00884838085282(21) 722222 (01)00884838099210(21); (3) Azurion SM12: 722227 (01)00884838099227(21); (4) Azurion SM20: 722228 (01)00884838099234(21); (5) Azurion 7B12/12: 722067 (01)00884838085350(21) 722225 (01)00884838099265(21); (6) Azurion 7820/15: 722068 (01)00884838085367(21) 722226 (01)00884838099272(21); (7) Azurion 7M12: 722078 (01)00884838085251(21) 722223 (01)00884838099241(21); (8) Azurion 7M20: 722079 (01)00884838085268(21) 722224 (01)00884838099258(21), Software: R2.2.O, R2.2.1, R2.2.3, R2.2.5 and R2.2.6
Other Recalls from PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1350-2026 | Class II | Azurion 5 M12 System Model Numbers: (1)722227,... | Jan 26, 2026 |
| Z-1345-2026 | Class II | Azurion 3 M15 System Model Numbers: (1) 722064... | Jan 26, 2026 |
| Z-1348-2026 | Class II | Azurion 7 M12 System Model Numbers: (1)722078,... | Jan 26, 2026 |
| Z-1346-2026 | Class II | Azurion 7 B12 System Model Numbers:(1) 722067,... | Jan 26, 2026 |
| Z-1349-2026 | Class II | Azurion 7 M20 System Model Numbers: (1)722079,... | Jan 26, 2026 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.