Model note · ECG

Mortara ELI 380 resting interpretive electrocardiograph

Name: Mortara ELI 380 resting interpretive electrocardiograph
Brand: Mortara ELI 380

The ELI 380 is a Mortara high performance multichannel resting electrocardiograph in a clamshell case. A large colour LCD folds over a full size thermal printer, and the glass keyboard can be disinfected. It acquires through a cable or a wireless acquisition module and keeps a running buffer, so the user can pick any 10 seconds or let it suggest the 'Best 10'. It sends records over LAN, WLAN or USB to an ECG management system. Its recalls are mostly about data and connections: ECGs attached to the wrong patient's demographics in one workflow (2015), a radio that could drop the access point, and lead sets that might not withstand defibrillation.

Start 7-day free trial Ask Essentia about the ECG

The model

Maker, model and type.

Maker: Mortara Instrument, Inc. (later recalls issued by Welch Allyn and Baxter)
Model: ELI 380 resting interpretive electrocardiograph
Device type: ECG
Main document: Open the public document

Key specifications

What the public record says.

Item	Value	Source
FDA classification and clearance	Electrocardiograph, 21 CFR 870.2340, product code DPS; K142105 (5 September 2014), predicate ELI 350 (K082946)	Source
Use	Acquire, analyse, display and print ECGs; interpretation for physician over read; adults and pediatrics; mainly hospitals, also clinics and offices	Source
Acquisition	Simultaneous acquisition of all leads by direct cable or wireless patient connection (for example the AM12M module); running buffer with manual 10 second selection or automatic 'Best 10'	Source
Output and connectivity	Full size thermal writer for reports and real time rhythm strips; LAN, WLAN and USB transmission; retrieves and sends stored records	Source
Hardware	Clamshell design with high resolution colour LCD over the printer; full keyboard on chemically strengthened glass with pointing device; internal battery or AC; optional cart	Source

Recalls

Known FDA recalls.

Z-1483-20212021-03-31
ELI 380 with AM12M module software 1.5.1 did not meet IEC 60601-2-27 as labelled (27 units).
FDA record
Z-0553-20212020-11-11
Radio can disassociate from the wireless access point; fixed in software 2.4.3.
FDA record
Z-1810-20202020-03-18
Patient cables and lead sets may not meet the defibrillation withstand requirement (78,521 units across ELI models).
FDA record
Z-1796-20152015-05-29
ECG waveforms could be linked to a different patient's demographics on transmission (176 units).
FDA record

Safety

Safety warnings from the record.

In one workflow, waveforms from one patient could be filed under another patient's details when sent to the records system (2015). Source
Interpretations are only meaningful together with a physician's over read and other clinical information. Source

Sources

Where this note comes from.

Not covered: The ELI 380 user and service manuals were not read, so sampling rate, frequency response, battery capacity, weight and the error message list are not included. The ownership line follows the names on recall records; check the current owner before publishing. The design note is BMEssentia advice.

BMEssentia knowledge drafted from public information, reviewed by Hasan Khaled Ismail on 2026-10-24. Always follow the manufacturer's instructions for use and service manual.

ECG