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WELCH ALLYN, INC/MORTARA recalls ELI 380 Electrocardiograph - Product Usage: intended to be a high-performance, multichannel resting electrocardiograph.
Recalled December 16, 2020 · FDA recall Z-0553-2021 · WELCH ALLYN, INC/MORTARA
Hazard
The radio within the device can become disassociated with the wireless access point. · FDA Class II
Units
1,009 units
Sold at
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, Kuwait, Netherlands, New Zealand, Norway, Qatar, Switzerland, United Arab Emirates, United Kingdom.
Description
The radio within the device can become disassociated with the wireless access point.
Product
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.
Manufacturer(s)
WELCH ALLYN, INC/MORTARA
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →