Recall Z-0011-2022 ยท DPS Electrocardiograph
Welch Allyn Inc Mortara
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-BBA-ADFBD, ELI280-DDB-ACFAX, MLBUR280-81X, ELI280-CAA-ACEBX, ELI280-AAA-AAHBX, ELI280-DDB-BD
| Date | Sep 3, 2021 |
| Status | Open, Classified |
| Reason | The devices malfunction under specific operator workflows. |
| Root cause | Software design |
| Action | The firm notified its consignees on 9/3/2021 by letter via U PS or via USPS first class for those with P.O. Box mailing addresses. The letter notified customers of the issue, provided clinical mitigations and advised them not to utilize specific workflows until their software is updated. |
| Quantity | 14,630 units |
| 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, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K122073 | ELI 280 ELECTROCARDIOGRAPH Mortara Instrument, Inc., Aug 2, 2012 |