CLASS II ONGOING Device recall · Reported 25 Sep 2024 · FDA Enforcement Report
System Code Name: 722282 Azurion 7 M20 722281 Azurion 5 M20 recalled
Philips Medical Systems Nederland B.v is recalling System Code Name: 722282 Azurion 7 M20 722281 Azurion 5 M20 722236, distributed nationwide in the US. The recall was initiated on 22 Aug 2024 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-3165-2024
- FDA event ID
- 95256
- Recalling firm
- Philips Medical Systems Nederland B.v, Best
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 22 Aug 2024
- FDA classified
- 18 Sep 2024
- Reported
- 25 Sep 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Foreign Material
- Device type
- Other Medical Devices
Timeline
| 22 Aug 2024 | Recall initiated by company | |
| 18 Sep 2024 | Classified by FDA | +27 days |
| 25 Sep 2024 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
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
Where it was distributed
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
Questions about this recall
Is System Code Name: 722282 Azurion 7 M20 722281 Azurion 5 M20 722236 recalled?
Yes. Philips Medical Systems Nederland B.v recalled System Code Name: 722282 Azurion 7 M20 722281 Azurion 5 M20 722236 on 22 Aug 2024. The recall is Class II and its status is Ongoing. Recall number Z-3165-2024.
Why was it recalled?
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.
Which lots are affected?
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
Where was it sold?
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
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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