FDASeptember 3, 2021device

ELI, Burdick and McKesson brand 280 Resting Electrocardiographs (ELI 280, MLBUR280 and BUR280), Model Numbers: ELI280-DDB-ADAAX, ELI280-BDB-ACAAX, ELI280-CAA-AAFAD, ELI280-BDB-BDFAX, ELI280-BCB-AAAAX, ELI280-DDB-ACAAX, ELI280-DBA-BAFAX, ELI280-DCB-AAAAX, ELI280-DBA-AAFBD, ELI280-AAA-AAEBX, ELI280...

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

The hazard

The devices malfunction under specific operator workflows.

What to do

FDA enforcement status: Ongoing

Brands named

welch allyn inc mortarawelchwelch allyn

UPCs

116280503226121250000503

Recall history

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

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