Device recall
Z-2345-2012: Volcano brand Intravascular Ultrasound, Volcano s5/s5i Family Software Version…
FDA device recall · Class II · Volcano Corporation
Key facts
| Recall number (Z-number) | Z-2345-2012 |
|---|---|
| Recall event | 63102 |
| Product | Volcano brand Intravascular Ultrasound, Volcano s5/s5i Family Software Version 3.2.1 or 3.2.2, Models/Part Numbers: 435-0607.01, 435-0607.04, 435-0602.01, 435-0602.02; Product is manufactured and distributed by Volcano Corporation, Rancho Cordova, CA. Medical device for use in imaging of histology. |
| Product code | IYO |
| Recalling firm | Volcano Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 25, 2014 |
| 510(k) numbers | K082229, K111706 |
| 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