Device recall
Z-1350-2026: Azurion 5 M12 System Model Numbers: (1)722227, (2)722231; Software Version…
FDA device recall · Class II · PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Key facts
| Recall number (Z-number) | Z-1350-2026 |
|---|---|
| Recall event | 98326 |
| Product | Azurion 5 M12 System Model Numbers: (1)722227, (2)722231; Software Version Number - All versions: R1.X, R2.X, R3.X |
| Product code | OWB |
| Recalling firm | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K172822, K181830, 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