System Code Name: 722282 Azurion 7 M20 722281 Azurion 5 M20 722236 Azurion 7 B20 722235 Azurion 7...
FDA Device Recall #Z-3165-2024 — Class II — August 22, 2024
Recall Summary
| Recall Number | Z-3165-2024 |
| Classification | Class II — Moderate risk |
| Date Initiated | August 22, 2024 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Location | Best |
| Product Type | Devices |
| Quantity | 7091 units |
Product Description
System Code Name: 722282 Azurion 7 M20 722281 Azurion 5 M20 722236 Azurion 7 B20 722235 Azurion 7 B12 722234 Azurion 7 M20 722233 Azurion 7 M12 722228 Azurion 5 M20 722227 Azurion 5 M12 722226 Azurion 7 B20 722225 Azurion 7 B12 722224 Azurion 7 M20 722223 Azurion 7 M12 722222 Azurion 3 M15 722221 Azurion 3 M12 722079 Azurion 7 M20 722078 Azurion 7 M12 722068 Azurion 7 B20 722067 Azurion 7 B12 722064 Azurion 3 M15 722063 Azurion 3 M12
Reason for Recall
Potential Detachment of the Cable Hose Carrier (due to broken plastic and/or bolts) which May Result in Parts Falling and/or Part of the Cable Hose Dropping, and result in injury.
Distribution Pattern
Nationwide, Canada and Worldwide: Albania Algeria Argentina Armenia Australia Austria Azerbaijan Bahrain Bangladesh Belarus Belgium Bolivia Bosnia and Herzegovina Brazil Brunei Darussalam Bulgaria Cambodia Cayman Islands Chile China Colombia Costa Rica C¿te D'Ivoire Croatia Cuba Curacao Cyprus Czech Republic Denmark Dominican Republic Ecuador Egypt Estonia Ethiopia Fiji Finland France French Polynesia Georgia Germany Ghana Gibraltar Greece Guadeloupe Guinea Honduras Hong Kong Hungary Iceland India Indonesia Iran Iraq Ireland Israel Italy Jamaica Japan Jordan Kazakhstan Kenya Korea, Republic of Kosovo Kuwait Kyrgyzstan Lao People's Democratic Republic Latvia Lebanon Libya Lithuania Macao Macedonia Malaysia Maldives Malta Martinique Mauritania Mauritius Mexico Mongolia Morocco Myanmar Nepal Netherlands New Caledonia New Zealand Nicaragua Norway Oman Pakistan Palestine, State of Panama Papua New Guinea Paraguay Peru Philippines Poland Portugal Qatar R¿union Romania Russian Federation Saudi Arabia Senegal Serbia Singapore Slovakia Slovenia South Africa Spain Sri Lanka Sudan Sweden Switzerland Syrian Arab Republic Taiwan Tanzania Thailand Trinidad and Tobago Tunisia Turkey Turkmenistan Ukraine United Arab Emirates United Kingdom Uruguay Uzbekistan Venezuela Viet Nam Virgin Islands (U.S.) Yemen
Lot / Code Information
Model Product UDI-DI: 1. 722282 Azurion 7 M20 (01)00884838110571(21); 2. 722281 Azurion 5 M20 (01)00884838110564(21); 3. 722236 Azurion 7 B20 (01)00884838116801(21); 4. 722235 Azurion 7 B12 (01)00884838116788(21); 5. 722234 Azurion 7 M20 (01)00884838116771(21); 6. 722233 Azurion 7 M12 (01)00884838116764(21); 7. 722228 Azurion 5 M20 (01)00884838099234(21); 8. 722227 Azurion 5 M12 (01)00884838099227(21); 9. 722226 Azurion 7 B20 (01)00884838099272(21); 10. 722225 Azurion 7 B12 (01)00884838099265(21); 11. 722224 Azurion 7 M20 (01)00884838099258(21); 12. 722223 Azurion 7 M12 (01)00884838099241(21); 13. 722222 Azurion 3 M15 (01)00884838099210(21); 14. 722221 Azurion 3 M12 (01)00884838099203(21); 15. 722079 Azurion 7 M20 (01)00884838085268(21); 16. 722078 Azurion 7 M12 (01)00884838085251(21); 17. 722068 Azurion 7 B20 (01)00884838085367(21); 18.722067 Azurion 7 B12 (01)00884838085350(21); 19. 722064 Azurion 3 M15 (01)00884838085282(21); 20. 722063 Azurion 3 M12 (01)00884838085275(21) All serial numbers
Other Recalls from PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1346-2026 | Class II | Azurion 7 B12 System Model Numbers:(1) 722067,... | Jan 26, 2026 |
| Z-1350-2026 | Class II | Azurion 5 M12 System Model Numbers: (1)722227,... | Jan 26, 2026 |
| Z-1349-2026 | Class II | Azurion 7 M20 System Model Numbers: (1)722079,... | Jan 26, 2026 |
| Z-1348-2026 | Class II | Azurion 7 M12 System Model Numbers: (1)722078,... | Jan 26, 2026 |
| Z-1345-2026 | Class II | Azurion 3 M15 System Model Numbers: (1) 722064... | 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.