FDA Device recall Z-0553-2021
ELI 380 Electrocardiograph - Product Usage: intended to be a high-performance, multichannel resting electrocardiograph
- FDA Device
- Class II
- terminated
- Published 2020-12-16
On 2020-12-16 the FDA classified a Class II recall of ELI 380 Electrocardiograph - Product Usage: intended to be a high-performance, multichannel resting electrocardiograph by Welch Allyn Mortara, citing the radio within the device can become disassociated with the wireless access point.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0553-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-11-11 |
| Published | 2020-12-16 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Welch Allyn Mortara |
| Distribution | US |
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
The radio within the device can become disassociated with the wireless access point.
Identifiers
| code_info | Part Number Device Identifier ELI380-ABS12 00732094265545 ELI380-ABX12 00732094265514 ELI380-A…Part Number Device Identifier ELI380-ABS12 00732094265545 ELI380-ABX12 00732094265514 ELI380-ACQ12 00732094319439 ELI380-ACS11 00812345026313 ELI380-ACX11 00812345024531 ELI380-ACX12 00732094265439 ELI380-ACX21 00812345024562 ELI380-ACX22 00732094265422 ELI380-ACX32 00732094265415 ELI380-DAS44 00732094265354 ELI380-DBX12 00732094265286 ELI380-DBX22 00732094265279 ELI380-DCP12 00732094301670 ELI380-DCQ11 00732094307870 ELI380-DCS11 00812345026917 ELI380-DCS12 00732094265248 ELI380-DCS21 00812345026924 ELI380-DCS43 00812345026948 ELI380-DCT12 00732094265217 ELI380-DCX11 00812345026979 ELI380-DCX12 00732094265200 ELI380-DCX21 00812345026986 ELI380-DCX22 00732094265194 ELI380-DCX32 00732094265187 ELI380-DCX43 00812345027006 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0553-2021%22
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