ELI 280 BUR280-C1DRecalls & reported problems
Mortara Instrument, Inc. · Electrocardiograph · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00812345024913), received between Jan 16, 2023 and Jan 16, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Improper or Incorrect Procedure or Method1
- Patient Data Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 16, 2023Improper or Incorrect Procedure or Method; Patient Data Problem; Improper or Incorrect Procedure or Method; Patient Data Problem
THE CUSTOMER REPORTED HAVING ISSUES ON THE ELI280 WHICH BEGAN AFTER INSTALLING SOFTWARE VERSION 2.4.1.8 IT WAS REPORTED THAT WHEN THE STAFF SELECTED "ERASE" TO ERASE AN EKG, IT REMAINED IN THE DIRECTORY AND THE WRONG PATIENT DEMOGRAPHICS WERE ON THE EKG PRINTOUT. THIS INCIDENT WAS CAPTURED UNDER HILLROM COMPLAINT REF # (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16173233 ↗
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, ClassifiedELI, 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 · TerminatedELI 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
Other Electrocardiograph devices
- ELI 380 ELI380-DCS11Mortara Instrument, Inc. · Electrocardiograph1 recall1 death70 reports
- Cardiac Workstation Cardiac Workstation 7000Philips Medizin Systeme Böblingen GmbH · Electrocardiograph2 recalls17 reports
- MAC VU360GE Medical Systems Information Technologies, Inc. · Electrocardiograph2 recalls1 report
- Q-Stress QSERV-6AA-XXXXBMortara Instrument, Inc. · Electrocardiograph2 recalls1 report
- Cardiac Workstation Cardiac Workstation 5000Philips Medizin Systeme Böblingen GmbH · Electrocardiograph2 recalls1 report
- Welch Allyn, Inc. 901049Welch Allyn, Inc. · ELECTROCARDIOGRAPH2 recalls0 reports
- Q-Stress QS6-AXTDSMortara Instrument, Inc. · Electrocardiograph2 recalls0 reports
- Q-Stress QS-6BD-ACAABMortara Instrument, Inc. · Electrocardiograph2 recalls0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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