Device recall
Z-1483-2021: ELI 380 Electrocardiograph, with AM12M Acquisition Module accessory. Impacted…
FDA device recall · Class II · Welch Allyn Inc Mortara
Key facts
| Recall number (Z-number) | Z-1483-2021 |
|---|---|
| Recall event | 87686 |
| Product | ELI 380 Electrocardiograph, with AM12M Acquisition Module accessory. Impacted software version of the AM12M is version 1.5.1 - Product Usage: indicated for use on adult and pediatric populations. |
| Product code | DPS |
| Recalling firm | Welch Allyn Inc Mortara |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 16, 2024 |
| 510(k) numbers | K142105 |
| FEI number | 2183461 |
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