Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
ELI 380 Electrocardiograph Recalled by Welch Allyn Inc Mortara Due to Devices do not meet IEC 60601-2-27 requirements as...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Welch Allyn Inc Mortara directly.
Affected Products
ELI 380 Electrocardiograph, with AM12M Acquisition Module accessory. Impacted software version of the AM12M is version 1.5.1 - Product Usage: indicated for use on adult and pediatric populations.
Quantity: 27 units
Why Was This Recalled?
Devices do not meet IEC 60601-2-27 requirements as labeled.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Welch Allyn Inc Mortara
Welch Allyn Inc Mortara has 5 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report