Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

ELI 380 Electrocardiograph - Product Usage: intended to be a high-performance Recalled by WELCH ALLYN, INC/MORTARA Due to The radio within the device can become disassociated...

Date: November 11, 2020
Company: WELCH ALLYN, INC/MORTARA
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact WELCH ALLYN, INC/MORTARA directly.

Affected Products

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.

Quantity: 1,009 units

Why Was This Recalled?

The radio within the device can become disassociated with the wireless access point.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About WELCH ALLYN, INC/MORTARA

WELCH ALLYN, INC/MORTARA has 11 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report