Device recall
Z-2880-2020: CARTO 3 System (Software Version V7.1.80), CARTO VISITAG Module - Product Usage…
FDA device recall · Class II · Biosense Webster (israel), Ltd.
Key facts
| Recall number (Z-number) | Z-2880-2020 |
|---|---|
| Recall event | 85910 |
| Product | CARTO 3 System (Software Version V7.1.80), CARTO VISITAG Module - Product Usage: FGThe intended use of the system is catheter-based cardiac electrophysiological (EP) procedures. The system provides information about the electrical activity of the heart and about catheter location during the… |
| Product code | DQK |
| Recalling firm | Biosense Webster (israel), Ltd. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 6, 2022 |
| 510(k) numbers | K191660 |
| FEI number | 3008203003 |
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