Device recall
Z-0901-2022: IntraSight Mobile IVUS Systems, Model: 797415, Part numbers: 300002018101…
FDA device recall · Class III · Volcano Corp
Key facts
| Recall number (Z-number) | Z-0901-2022 |
|---|---|
| Recall event | 89677 |
| Product | IntraSight Mobile IVUS Systems, Model: 797415, Part numbers: 300002018101, 300002018102 |
| Product code | IYO |
| Recalling firm | Volcano Corp |
| Recall class | Class III |
| Status | Open, Classified |
| 510(k) numbers | K203719 |
| FEI number | 3008363989 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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