Device recall
Z-0553-2021: ELI 380 Electrocardiograph - Product Usage: intended to be a high-performance…
FDA device recall · Class II · WELCH ALLYN, INC/MORTARA
Key facts
| Recall number (Z-number) | Z-0553-2021 |
|---|---|
| Recall event | 86716 |
| Product | ELI 380 Electrocardiograph - Product Usage: intended to be a high-performance, multichannel resting electrocardiograph. As a resting electrocardiograph, the ELI 380 simultaneously acquires data from each lead. |
| Product code | DPS |
| Recalling firm | WELCH ALLYN, INC/MORTARA |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 8, 2023 |
| FEI number | 2183461 |
At a glance
- None 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