Device recall
Z-1810-2020: Lead diagnostic electrocardiograph under the following device names: ELI 10, ELI…
FDA device recall · Class II · WELCH ALLYN, INC/MORTARA
Key facts
| Recall number (Z-number) | Z-1810-2020 |
|---|---|
| Recall event | 85297 |
| Product | Lead diagnostic electrocardiograph under the following device names: ELI 10, ELI 350, ELI 150c, ELI 250c, ELI 230, ELI 280, ELI 380, R-Scribe and Connex Cardio. Product Usage: A non-invasive prescription device indicated for use to acquire, analyze, display, transmit and print electrocardiograms. |
| Product code | DPS |
| Recalling firm | WELCH ALLYN, INC/MORTARA |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 9, 2026 |
| 510(k) numbers | K092663, K102206 |
| FEI number | 2183461 |
At a glance
- 1–9 Linked 510(k)s
- 10–99 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