Device recall
Z-1190-2007: Volcano s5 Imaging system, Ultrasound pulsed echo imaging system. Product…
FDA device recall · Class III · Volcano Corporation
Key facts
| Recall number (Z-number) | Z-1190-2007 |
|---|---|
| Recall event | 38324 |
| Product | Volcano s5 Imaging system, Ultrasound pulsed echo imaging system. Product consists of the CPU, control console, monitor, printer, and patient interface module (PIM) |
| Product code | IYO |
| Recalling firm | Volcano Corporation |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Jun 3, 2008 |
| 510(k) numbers | K051920 |
| 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