ELI 280 Electrocardiograph — Class II medical device recall Z-1482-2021
Terminated recall by Welch Allyn Inc Mortara, reported 2021-04-28, distributed nationwide. Devices do not meet IEC 60601-2-27 requirements as labeled.
| Recall number | Z-1482-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Welch Allyn Inc Mortara, Milwaukee, WI, United States |
| Recall initiated | 2021-03-31 |
| Classified | 2021-04-22 |
| Reported by FDA | 2021-04-28 |
| Terminated | 2024-08-16 |
| Distributed | Nationwide (US) |
| Quantity | 99 units |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 00118150627678, 00118230000568, 00118230000575, 00118230000582, 00118340001622, 00118400001470, 00118420000071, 00119150000003, 00119150000010, 00119180001155, 00119260000443, 00119290001052, 00119480000193, 00732094265644, 00732094265675, 00732094265682, 00732094265699, 00732094319941 |
| Model numbers | ELI280-LDB-ADAAX, ELI280-LDD-AAABX, ELI280-LDX-ADABX, ELI280-LDX-ADFBD, ELI280-LDX-ADFBG |
Product
ELI 280 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.
Reason for recall
Devices do not meet IEC 60601-2-27 requirements as labeled.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1482-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.