Device recall
Z-1256-2020: EDAN Telemetry Transmitter, Model iT20 - Product Usage: The iT20 telemetry…
FDA device recall · Class II · Edan Diagnostics
Key facts
| Recall number (Z-number) | Z-1256-2020 |
|---|---|
| Recall event | 84790 |
| Product | EDAN Telemetry Transmitter, Model iT20 - Product Usage: The iT20 telemetry transmitter is intended to be used in clinical divisions of hospital environments, including CCU and general wards (as Cardiology Dept.) |
| Product code | MHX |
| Recalling firm | Edan Diagnostics |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 28, 2022 |
| 510(k) numbers | K161056 |
| FEI number | 3009499478 |
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