Device recall
Z-0168-2011: Volcano s5/s5i imaging system Family Software version 3.2, Part Numbers…
FDA device recall · Class II · Volcano Corporation
Key facts
| Recall number (Z-number) | Z-0168-2011 |
|---|---|
| Recall event | 56794 |
| Product | Volcano s5/s5i imaging system Family Software version 3.2, Part Numbers 435-0602.01 to 05, including ChromaFlo and Virtual Histology, manufactured by Volcano Corporation of Rancho Cordova, CA. |
| Product code | IYO |
| Recalling firm | Volcano Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 22, 2010 |
| 510(k) numbers | K082229 |
| 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