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

Class I - Dangerous

🏥 Medical Devices Recalled: August 22, 2024 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Other Medical Devices Nationwide

What Should You Do?

Check if you have this product:
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
Do not eat it: Even if it looks and smells fine, do not consume this product.
Throw it away or return it: You can return the product to the store for a full refund.
Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
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.
Classification:: Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
Status:: ongoing

Product Information

Full 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

Product Codes/Lot Numbers:

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

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-3165-2024

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