Device recall
Z-3014-2026: Alphenix Models INFX-8000C INFX-8000F INFX-8000V This device is a digital…
FDA device recall · Class II · Canon Medical System, USA, INC.
Key facts
| Recall number (Z-number) | Z-3014-2026 |
|---|---|
| Recall event | 99222 |
| Product | Alphenix Models INFX-8000C INFX-8000F INFX-8000V This device is a digital radiography/fluoroscopy system used in a diagnostic and interventional angiography configuration. The system is indicated for use in diagnostic and angiographic procedures for blood vessels in the heart, brain, abdomen and… |
| Product code | OWB |
| Recalling firm | Canon Medical System, USA, INC. |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K182415, K203551, K210900 |
| FEI number | 2020563 |
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