FDA Device recall Z-1483-2021

ELI 380 Electrocardiograph, with AM12M Acquisition Module accessory

FDA Device
Class II
terminated
Published 2021-04-28

On 2021-04-28 the FDA classified a Class II recall of ELI 380 Electrocardiograph, with AM12M Acquisition Module accessory by Welch Allyn Mortara, citing devices do not meet IEC 60601-2-27 requirements as labeled.

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-1483-2021
Classification	Class II
Status	terminated
Initiated	2021-03-31
Published	2021-04-28
Last updated	2026-09-13 11:56 UTC
Company	Welch Allyn Mortara
Distribution	US

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.

Reason

Devices do not meet IEC 60601-2-27 requirements as labeled.

Identifiers

code_info	Part Number: ELI380-ACX32 (Device Identifier: 732094265415); S/N: 118490001284, 119150000588, 120090001355, 12009000135… Part Number: ELI380-ACX32 (Device Identifier: 732094265415); S/N: 118490001284, 119150000588, 120090001355, 120090001354 Part Number: ELI380-DAX3X (Device Identifier: 812345026757); S/N: 117120557018, 117120557019, 117120557020, 117120557021, 117230571942, 117230571943, 117270577469 Part Number: ELI380-DBX32 (Device Identifier: 732094265262); S/N: 118180634420 Part Number: ELI380-DCX32 (Device Identifier: 732094265187); S/N: 118340001074, 118340001074, 118340001075, 118500001332, 118460001178, 119150000120, 119210000774, 119290000580, 119520000194, 120080001509, 120080001510, 120100000310, 120080001511, 120110002478, 120170000570

code_info

Part Number: ELI380-ACX32 (Device Identifier: 732094265415); S/N: 118490001284, 119150000588, 120090001355, 12009000135…

Part Number: ELI380-ACX32 (Device Identifier: 732094265415); S/N: 118490001284, 119150000588, 120090001355, 120090001354 Part Number: ELI380-DAX3X (Device Identifier: 812345026757); S/N: 117120557018, 117120557019, 117120557020, 117120557021, 117230571942, 117230571943, 117270577469 Part Number: ELI380-DBX32 (Device Identifier: 732094265262); S/N: 118180634420 Part Number: ELI380-DCX32 (Device Identifier: 732094265187); S/N: 118340001074, 118340001074, 118340001075, 118500001332, 118460001178, 119150000120, 119210000774, 119290000580, 119520000194, 120080001509, 120080001510, 120100000310, 120080001511, 120110002478, 120170000570

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1483-2021%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.