Device recall
Z-0973-2012: Volcano pcFM Software Kit; Manufactured by: Volcano Corporation, 2870 Kilgore…
FDA device recall · Class II · Volcano Corporation
Key facts
| Recall number (Z-number) | Z-0973-2012 |
|---|---|
| Recall event | 60867 |
| Product | Volcano pcFM Software Kit ; Manufactured by: Volcano Corporation, 2870 Kilgore Road, Rancho Cardova, CA 95624. The volcano pcFM Software Kit is a research only off line tool intended for review and printout of physiological measurements recorded by ComboMap System. It is not intended for analysis or… |
| Product code | IYO |
| Recalling firm | Volcano Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 7, 2012 |
| FEI number | 2939520 |
At a glance
- None 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