Device recall
Z-2776-2016: CARTO 3 EP Navigation System and Accessories, Product Codes: FG540000 and…
FDA device recall · Class II · Biosense Webster, Inc.
Key facts
| Recall number (Z-number) | Z-2776-2016 |
|---|---|
| Recall event | 75012 |
| Product | CARTO 3 EP Navigation System and Accessories, Product Codes: FG540000 and FG540000C, Software Versions: v 3.2 , v 4.3 and v 2.3. The CARTO 3 EP Navigation System is intended to be used in catheter-based cardiac electrophysiological (EP) procedures. The CARTO 3 System provides information about the… |
| Product code | DQK |
| Recalling firm | Biosense Webster, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 20, 2017 |
| 510(k) numbers | K112007, K132782, K133916 |
| FEI number | 3003113629 |
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