Device recall
Z-2132-2015: Volcano s5/s5i/CORE Intravascular Ultrasound Systems software versions 3.3 and…
FDA device recall · Class II · Volcano Corporation
Key facts
| Recall number (Z-number) | Z-2132-2015 |
|---|---|
| Recall event | 71654 |
| Product | Volcano s5/s5i/CORE Intravascular Ultrasound Systems software versions 3.3 and 3.4 (with and without iFR Scout Technology) and v.3.4 software kits; Model s5x. Radiology: The Volcano s5/s5i and CORE Series Intravascular Imaging and Pressure System is used for the qualitative and quantitative… |
| Product code | IYO |
| Recalling firm | Volcano Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 14, 2017 |
| 510(k) numbers | K123898 |
| FEI number | 2939520 |
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