Welch Allyn, Inc. 901133 (REF ELI380-DCS12)Recalls & reported problems
Welch Allyn, Inc. · ELI380 12-Lead Multi-Channel Electrocardiograph - Capacitive color touchscreen 17 in. swivel display (ERGO) with 1280 x 1024 resolution, English keyboard, AC or lithium ion battery operation includes 1 starter pack paper (Smart Paper 8.27 in. x 11 in.), ECG clip adapters (set of 10) and tab electrodes (pouch of 100); current software; adult and pediatric interpretation; Advanced Connectivity includes WLAN, LAN, USB, DICOM, and Enterprise; Security ; WAM Wireless Acquisition Module; IEC 10 wire, · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00732094265248), received between Feb 9, 2022 and Apr 7, 2022 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Intermittent Communication Failure” (2 reports).
1 FDA recall record name this device's identifier.
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.
Recalls naming this device
- Nov 11, 2020Class IITerminated
The radio within the device can become disassociated with the wireless access point.
Z-0553-2021 · Root cause: Software design · Recall details · FDA record ↗
Most reported problems
Device problems
- Intermittent Communication Failure2
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.
MalfunctionApr 7, 2022Intermittent Communication Failure; Intermittent Communication Failure
THE CUSTOMER REPORTED THAT THEIR ELI 380 UNIT KEEPS DISCONNECTING FROM THE WIFI AND CUSTOMER IS UNABLE TO LOG-IN AND USE THE MACHINE. THERE WAS NO PATIENT/USER INJURY REPORTED. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT # (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14044883 ↗MalfunctionFeb 9, 2022Intermittent Communication Failure; Intermittent Communication Failure
THE CUSTOMER REPORTED THAT THEIR ELI 380 UNIT KEEPS DISCONNECTING FROM THE WIFI AND IS UNABLE TO LOG-IN AND USE THE MACHINE. THERE WAS NO PATIENT/USER INJURY REPORTED. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT # C-(B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13498484 ↗
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- MAC VU360GE Medical Systems Information Technologies, Inc. · Electrocardiograph2 recalls1 report
- 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 · each recall links to the FDA recall notice
- 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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