ELI 380 ELI380-ACS21Recalls & reported problems
Mortara Instrument, Inc. · Electrocardiograph · Class 2
All models of ELI 380 (11)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00812345026603), received between May 26, 2025 and Jul 3, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Wireless Communication Problem” (2 reports).
3 other recalls cover devices cleared under the same FDA submission (K142105); 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Wireless Communication Problem2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 3, 2025Wireless Communication Problem; Wireless Communication Problem
CUSTOMER REPORTED THE CONNECTION ISSUES. THERE WAS NO ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22394389 ↗MalfunctionMay 26, 2025Wireless Communication Problem; Wireless Communication Problem
CUSTOMER REPORTED CART NOT COMMUNICATING VIA WIRELESS. THIS COMPLAINT WAS CAPTURED UNDER HILLROM REF # (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22083809 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K142105. One submission often covers many models, so check the product and lot details in each record.
- Z-1013-2023 · Oct 31, 2022 · TerminatedBaxter Electrocardiograph, ELI 380 -DCS21
- Z-1483-2021 · Mar 31, 2021 · TerminatedELI 380 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
- Z-1796-2015 · May 29, 2015 · TerminatedELI 380 Electrocardiograph. The ELI 380 is intended to be a high-performance, multichannel resting electrocardiograph. As a resting electrocardiograph, the ELI 380 simultaneously a
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- XScribe Cardiopulmonary Kit 41000-030-60Mortara Instrument, Inc. · Electrocardiograph2 recalls0 reports
- Welch Allyn, Inc. 901049Welch Allyn, Inc. · ELECTROCARDIOGRAPH2 recalls0 reports
- Welch Allyn, Inc. 901133Welch Allyn, 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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