Device recall
Z-1891-2018: Philips Volcano CORE M2 Vascular System, Part # 400-0100.17, Rx Only. Used for…
FDA device recall · Class II · Volcano Corporation
Key facts
| Recall number (Z-number) | Z-1891-2018 |
|---|---|
| Recall event | 79715 |
| Product | Philips Volcano CORE M2 Vascular System, Part # 400-0100.17, Rx Only. Used for the qualitative and quantitative evaluation of vascular morphology in the coronary arteries and vessels of the peripheral vasculature. |
| Product code | IYO |
| Recalling firm | Volcano Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 28, 2021 |
| 510(k) numbers | K172455 |
| 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