Welch Allyn ELI 280 Resting ECGs Malfunction Under Specific Workflows
Welch Allyn recalls ELI 280 Resting Electrocardiographs with specific model numbers and software versions due to malfunction under certain operator workflows. No remedy stated in official notice.
Recall notice
The devices malfunction under specific operator workflows.
Contact the company
What happened, in plain English
Welch Allyn is recalling ELI 280 Resting Electrocardiographs that may malfunction under specific operator workflows. This could lead to incorrect heart monitoring readings if used improperly. Read more at govinfonow.com/recall/61834-welch-allyn-eli-280-resting-ecgs-malfunction-under-specific-workflows.
Source Summary by GovInfoNow · govinfonow.com/recall/61834-welch-allyn-eli-280-resting-ecgs-malfunction-under-specific-workflows · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0011-2022
Cite this page
“Welch Allyn ELI 280 Resting ECGs Malfunction Under Specific Workflows.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61834-welch-allyn-eli-280-resting-ecgs-malfunction-under-specific-workflows. Based on FDA recall #Z-0011-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0011-2022%22&limit=1).
Why it’s dangerous
The devices malfunction when used with specific operator workflows, potentially causing incorrect heart monitoring readings. This could lead to misdiagnosis or delayed treatment if the malfunction occurs during critical patient monitoring.
Who’s affected
Healthcare professionals using these electrocardiographs for patient monitoring are most at risk. The recall affects devices sold between July 2016 and July 2021.
How to tell if you have this one
Check for model numbers listed in the recall notice or software versions 2.1.0-2.3.0. Devices were manufactured from July 2016 to July 2021.
- Brand
Welch Allyn Inc Mortara- Category
Medical device
What to do — step by step
Check Model Numbers
Look for model numbers like ELI280-DDB-ADAAX or MLBUR280-81X on the device.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA distribution: “Distribution was nationwide, including Puerto Rico. Foreign distribution was made to Afghanistan, Angola, Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 40 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-0011-2022 (September 3, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0011-2022 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.