Device recall
Z-1811-2020: ELI PC. The ELI PC Service automatically converts resting ECG recordings…
FDA device recall · Class II · WELCH ALLYN, INC/MORTARA
Key facts
| Recall number (Z-number) | Z-1811-2020 |
|---|---|
| Recall event | 85297 |
| Product | ELI PC. The ELI PC Service automatically converts resting ECG recordings collected with WAM PC patient cables and WebUpload into DICOM 12-lead ECG Waveform files. |
| Product code | DPS |
| Recalling firm | WELCH ALLYN, INC/MORTARA |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 9, 2026 |
| 510(k) numbers | K093339 |
| 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