FDANovember 11, 2020device

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.

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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

What to do

FDA enforcement status: Terminated

Brands named

welch allyn inc mortarawelchwelch allyn

UPCs

007320942655450073209426551400732094319439008123450263130081234502453100732094265439008123450245620073209426542200732094265415007320942653540073209426528600732094265279

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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