Device recall
Z-1813-2016: Volcano s5, s5i, CORE and CORE Mobile systems with software version 3.4 and v3.4…
FDA device recall · Class II · Volcano Corporation
Key facts
| Recall number (Z-number) | Z-1813-2016 |
|---|---|
| Recall event | 73984 |
| Product | Volcano s5, s5i, CORE and CORE Mobile systems with software version 3.4 and v3.4 software kits. Cardiology: The Volcano Universal (Core /Core Mobile), S5iz Platform Imaging System is used for the qualitative and quantitative evaluation of vascular morphology in the coronary arteries and vessels of… |
| Product code | OBJ |
| Recalling firm | Volcano Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 2, 2018 |
| 510(k) numbers | K071554, 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