Device recall
Z-3165-2024: System Code Name: 722282 Azurion 7 M20 722281 Azurion 5 M20 722236 Azurion 7 B20…
FDA device recall · Class II · PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Key facts
| Recall number (Z-number) | Z-3165-2024 |
|---|---|
| Recall event | 95256 |
| Product | 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… |
| Product code | OWB |
| Recalling firm | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K200917 |
| FEI number | 3002807880 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database