ELI 380 Electrocardiograph — Class II medical device recall Z-0553-2021
Terminated recall by WELCH ALLYN, INC/MORTARA, reported 2020-12-16, distributed nationwide. The radio within the device can become disassociated with the wireless access point.
| Recall number | Z-0553-2021 |
|---|---|
| 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 | 2020-11-11 |
| Classified | 2020-12-09 |
| Reported by FDA | 2020-12-16 |
| Terminated | 2023-08-08 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AU, CA, CH, CZ, DE, FI, GB, IT, KW, NL, NO, NZ, QA |
| Quantity | 1,009 units |
| UPC / GTIN / UDI-DI | 00732094265187, 00732094265194, 00732094265200, 00732094265217, 00732094265248, 00732094265279, 00732094265286, 00732094265354, 00732094265415, 00732094265422, 00732094265439, 00732094265514, 00732094265545, 00732094301670, 00732094307870, 00732094319439, 00812345024531, 00812345024562, 00812345026313, 00812345026917, 00812345026924, 00812345026948, 00812345026979, 00812345026986, 00812345027006 |
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.
Reason for recall
The radio within the device can become disassociated with the wireless access point.
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-0553-2021. 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.