Device recall
Z-2043-2015: Volcano s5/s5x/CORE Mobile Intravascular Ultrasound Imaging and Pressure System…
FDA device recall · Class II · Volcano Corp
Key facts
| Recall number (Z-number) | Z-2043-2015 |
|---|---|
| Recall event | 71404 |
| Product | Volcano s5/s5x/CORE Mobile Intravascular Ultrasound Imaging and Pressure System; Product/Part numbers: s5 - 804200-002 and 804200-014; s5x - 807300-001; CORE MOBILE - 400-0100.01. Intravascular Imaging and Pressure System for evaluation of blood flow, perfusion and vascular structures. |
| Product code | IYO |
| Recalling firm | Volcano Corp |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 9, 2015 |
| 510(k) numbers | K123898 |
| 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