Device recall
Z-1845-2015: Prestige Plus 185cm J-Tip: Part number: 9185J; Product Usage: The Prestige Plus…
FDA device recall · Class II · Volcano Corporation
Key facts
| Recall number (Z-number) | Z-1845-2015 |
|---|---|
| Recall event | 71537 |
| Product | Prestige Plus 185cm J-Tip: Part number: 9185J; Product Usage: The Prestige Plus Wire is indicated for use to measure pressure in blood vessels including both coronary and peripheral vessels, during diagnostic angiography and/or any interventional procedures. Blood pressure measurements provide… |
| Product code | DQX |
| Recalling firm | Volcano Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 27, 2015 |
| 510(k) numbers | K111395 |
| FEI number | 2939520 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 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