Welch Allyn, Inc. 901133 (REF ELI380-DCX12)Recalls & reported problems

Welch Allyn, Inc. · ELI380 12-Lead Multi-Channel Electrocardiograph - Capacitive color touchscreen 17 in. swivel display (ERGO) with 1280 x 1024 resolution, English keyboard, AC or lithium ion battery operation includes 1 starter pack paper (Smart Paper 8.27 in. x 11 in.), ECG clip adapters (set of 10) and tab electrodes (pouch of 100); current software; adult and pediatric interpretation; Advanced Connectivity includes WLAN, LAN, USB, DICOM, and Enterprise; WAM Wireless Acquisition Module; IEC 10 wire, 12- lead l · Class 2

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports: 2
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 1

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00732094265200), received between Mar 15, 2024 and Oct 2, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Intermittent Communication Failure” (2 reports).

1 FDA recall record name this device's identifier.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Recalls naming this device

Nov 11, 2020Class IITerminated
The radio within the device can become disassociated with the wireless access point.
Z-0553-2021 · Root cause: Software design · Recall details · FDA record ↗

Most reported problems

Device problems

Intermittent Communication Failure2
Wireless Communication Problem2

Patient problems

No Clinical Signs, Symptoms or Conditions2

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

MalfunctionOct 2, 2025Wireless Communication Problem; Intermittent Communication Failure; Wireless Communication Problem; Intermittent Communication Failure
THE CUSTOMER REPORTED THE NETWORK AND WIFI WERE NOT WORKING PROPERLY. THERE WAS NO ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23198838 ↗
MalfunctionMar 15, 2024Wireless Communication Problem; Intermittent Communication Failure; Wireless Communication Problem; Intermittent Communication Failure
THE BIOMED REPORTED THAT AFTER THE DEVICE WAS REPAIRED, IT HAD UNSTABLE WIFI CONNECTION. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THIS INCIDENT WAS CAPTURED UNDER HILLROM COMPLAINT REF (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18912158 ↗

Device details

UDI-DI	`00732094265200`
Brand	Welch Allyn, Inc.
Model	901133
Catalog no.	ELI380-DCX12
Company	Welch Allyn, Inc.
Product code	DPS · Electrocardiograph
Class	Class 2
FDA submission	None listed
Implant	No
Rx / OTC	OTC
Single use	No
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Jun 27, 2022

Device type (GMDN): Electrocardiograph, professional, multichannel

A device intended to be used by a healthcare professional in a clinical setting to acquire and process the electrical activity of the heart for digital display in the form of a graph, to assist a physician in assessing electrical cardiac physiology [electrocardiography (ECG)]. It is designed for recording the electrical signal from two or more configurations of electrodes (ECG-leads) at a time (multichannel) and may be intended for resting ECG and/or stress/exercise ECG. It will either include an integrated display or be designed to transmit ECG data to an off-the-shelf device for display; ECG electrodes may be included. Data interpretation and/or telemetry features might also be included.

Other Electrocardiograph devices

ELI 380 ELI380-DCS11
Mortara Instrument, Inc. · Electrocardiograph
1 recall1 death70 reports
Cardiac Workstation Cardiac Workstation 7000
Philips Medizin Systeme Böblingen GmbH · Electrocardiograph
2 recalls17 reports
Q-Stress QSERV-6AA-XXXXB
Mortara Instrument, Inc. · Electrocardiograph
2 recalls1 report
Cardiac Workstation Cardiac Workstation 5000
Philips Medizin Systeme Böblingen GmbH · Electrocardiograph
2 recalls1 report
MAC VU360
GE Medical Systems Information Technologies, Inc. · Electrocardiograph
2 recalls1 report
XScribe Cardiopulmonary Kit 41000-030-60
Mortara Instrument, Inc. · Electrocardiograph
2 recalls0 reports
Welch Allyn, Inc. 901049
Welch Allyn, Inc. · ELECTROCARDIOGRAPH
2 recalls0 reports
Welch Allyn, Inc. 901133
Welch Allyn, Inc. · Electrocardiograph
2 recalls0 reports

All Electrocardiograph devices →

Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

How reports and recalls are matched · Editorial policy · Report an error on this page