Welch Allyn ELI 280 Electrocardiograph with AM12M Module Software Recalled for Safety

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Contact the company & request your remedy

Recalling firmWelch Allyn Inc Mortara7865 N 86th St, N/A · Milwaukee, WI 53224-3431

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✎ GovInfoNow plain-language explainer

What happened, in plain English

Welch Allyn is recalling ELI 280 Electrocardiograph devices with specific AM12M Acquisition Module software versions that do not meet safety standards. This could lead to potential safety issues during medical use.

Why it’s dangerous

The recalled devices do not meet IEC 60601-2-27 safety standards, which are designed to ensure medical devices operate safely. This could potentially lead to electrical malfunctions or other safety issues during use.

Who’s affected

Healthcare professionals using the ELI 280 Electrocardiograph with AM12M Acquisition Module software version 1.5.1 are most at risk. Patients using these devices may also be affected.

How to tell if you have this one

Check for the part numbers ELI280-LDB-ADAAX, ELI280-LDD-AAABX, ELI280-LDX-ADABX, ELI280-LDX-ADFBD, or ELI280-LDX-ADFBG with the specified serial numbers listed in the recall notice.

Brand
Welch Allyn
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Device Details
Verify your device's part number and serial number against the list provided in the recall notice to confirm if it is affected.

✎ GovInfoNow

Questions people ask

What software version is affected?

The affected software version of the AM12M Acquisition Module is version 1.5.1.

How can I tell if my device is recalled?

Check your device's part number and serial number against the list of affected units provided in the recall notice.

Is there a fix for this issue?

The recall notice does not specify a remedy or fix for this issue.

Take action

Contact Welch Allyn

We’ve drafted a message you can send Welch Allyn to request your refund or repair — edit it as you like.

✉️ Open in email

Subject: Recall Z-1482-2021 — Welch Allyn Welch Allyn

Hello,

I own a Welch Allyn that is covered by recall Z-1482-2021 from Welch Allyn.

I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this?

Thank you.

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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-1482-2021 (March 31, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1482-2021 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.

Welch Allyn Inc Mortara recalls ELI 280 Electrocardiograph, with AM12M Acquisition Module accessory. Impacted software version of the AM12M is version

Lower-risk recall