Device recall
Z-2657-2017: CardioTek EP-TRACER Software V1.x and V2.0 The EP-TRACER System is an…
FDA device recall · Class II · CardioTek BV
Key facts
| Recall number (Z-number) | Z-2657-2017 |
|---|---|
| Recall event | 77025 |
| Product | CardioTek EP-TRACER Software V1.x and V2.0 The EP-TRACER System is an electrophysiology measurement system used to acquire, filter, digitize, amplify, display, and record signals obtained during electrophysiological studies and related procedures. The system allows the user to monitor, display and… |
| Product code | DQK |
| Recalling firm | CardioTek BV |
| Recall class | Class II |
| Status | Completed |
| 510(k) numbers | K134044, K161245 |
| FEI number | 3008329188 |
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