ELI 280 ELI280-AAA-AAFBTRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00817655020709), received between Sep 1, 2022 and Sep 1, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Patient Data Problem” (1 report).

2 other recalls cover devices cleared under the same FDA submission (K122073); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 1, 2022Patient Data Problem; Patient Data Problem

  THE CUSTOMER REPORTED THAT THE ELI280 UNIT WILL HAVE AN INCORRECT PATIENT DISPLAYED AFTER TAKING AN ECG. THIS EVENT HAS BEEN CAPTURED UNDER HILLROM COMPLAINT REF # (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15337649 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K122073. One submission often covers many models, so check the product and lot details in each record.

• Z-0011-2022 · Sep 3, 2021 · Open, Classified
  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-B
• Z-1482-2021 · Mar 31, 2021 · Terminated
  ELI 280 Electrocardiograph, with AM12M Acquisition Module accessory. Impacted software version of the AM12M is version 1.5.1 - Product Usage: indicated for use on adult and pediat