Welch Allyn, Inc. 901132 (REF ELI280-LDB-ADAAX)Recalls & reported problems
Welch Allyn, Inc. · ELI280 12-Lead Multi-Channel Electrocardiograph - Resistive color touchscreen 10.1 in. display, AC or battery operation with AM12 Wired Acquisition Module (includes 1 starter pack paper - A4 with spacer for writer tray); for use with Quickels Decapus III or greater); current software; International power cord; IEC 10 wire, 12-lead lead set with banana plugs; Adult and pediatric interpretation; No accessories; USB Host; Standard storage (up to 40 ECGs); · 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
- Mar 31, 2021Class IITerminated
Devices do not meet IEC 60601-2-27 requirements as labeled.
Z-1482-2021 · Root cause: Process control · Recall details · FDA record ↗
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- 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.
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