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-BB
Check against the official notice below — it lists the full affected range.
Welch Allyn Inc is recalling 14,630 ELI, Burdick, and McKesson brand 280 Resting Electrocardiographs distributed nationwide and internationally due to malfunctions that occur under specific operator workflows. The affected devices include models ELI280-DDB-ADAAX, ELI280-BDB-ACAAX, ELI280-CAA-AAFAD, and ELI280-BDB with software versions 2.1.0 through 2.3.0 and serial numbers ranging from 116280503226 through 121250000503, manufactured between July 1, 2016 and July 1, 2021.
The recall notice does not specify a remedy or recommended action for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
The devices malfunction under specific operator workflows.
Reason for recall: The devices malfunction under specific operator workflows. Distribution: Distribution was nationwide, including Puerto Rico. Foreign distribution was made to Afghanistan, Angola, Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Czechia, Denmark, Dominican Republic, Ecuador, Finland, France, Germany, Guatemala, Hongkong, Hungary, India, Indonesia, Iran, Ireland, Is Quantity: 14,630 units Lot/code info: Software versions 2.1.0-2.3.0, Serial numbers 116280503226 thru 121250000503 manufactured from 01-July-2016 thru 01-Jul-2021.
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.