Welch Allyn, Inc. 901133 (REF ELI380-ACX12)Recalls & reported problems
Welch Allyn, Inc. · ELI380 12-Lead Multi-Channel Electrocardiograph - Color LCD 17 in. display 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; WAM Wireless Acquisition Module; IEC 10 wire, 12-lead lead set with banana plugs and EU p · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
No MAUDE adverse event reports in our data reference this device identifier directly.
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 ↗
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
- Q-Stress QSERV-6AA-XXXXBMortara Instrument, Inc. · Electrocardiograph2 recalls1 report
- Cardiac Workstation Cardiac Workstation 5000Philips Medizin Systeme Böblingen GmbH · Electrocardiograph2 recalls1 report
- 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
- 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.
How reports and recalls are matched · Editorial policy · Report an error on this page