Device recall
Z-3224-2018: Allura Xper FD2O Biplane, System Code 722008 Vascular, cardiovascular and…
FDA device recall · Class II · Philips Electronics North America Corporation
Key facts
| Recall number (Z-number) | Z-3224-2018 |
|---|---|
| Recall event | 80922 |
| Product | Allura Xper FD2O Biplane, System Code 722008 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diagnostics, Non-vascular interventions |
| Product code | IZI |
| Recalling firm | Philips Electronics North America Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 18, 2022 |
| 510(k) numbers | K033737 |
| FEI number | 1218950 |
At a glance
- 1–9 Linked 510(k)s
- 10–99 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