WELCH ALLYN, INC/MORTARA recalls ELI 380 Electrocardiograph - Product Usage: intended to be a high-performance, multichannel resting electrocardiograph.…

Recall date

November 11, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0553-2021

FDA classification

Class II

Brand / firm

WELCH ALLYN, INC/MORTARA

Sold / distributed

Worldwide distribution - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, FL, GA, HI, IN, KS, KY, MA, MD, MI, MO, MT, NC, ND, NH, NM, NV, NY, OH, OR, PA, SC, SD, TN, TX, UT, WA, WI, WV, WY and the countries of Australia, Canada, Czech, Finland, GB, Germany, Italy, Kuwai…

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.