Reported Apr 28, 2021 · Terminated
ELI 380 Electrocardiograph, with AM12M Acquisition Module accessory. Impacted software version of the AM12M is version…
Welch Allyn Inc. Mortara
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Welch Allyn Inc Mortara · 7865 N 86th St · Milwaukee, WI · 53224-3431
Is this the product you have?
- ELI 380 Electrocardiograph, with AM12M Acquisition Module accessory. Impacted software version of the AM12M is version 1.5.1 -
- Product Usageindicated for use on adult and pediatric populations
- Lot codes and dates
5 of 5 products
Products covered by this recall Model / number Barcodes Product as published ELI380-ACX32732094265415(Device Identifier: 732094265415) ELI380-DAX3X118490001284119150000588120090001355120090001354812345026757S/N: 118490001284, 119150000588, 120090001355, 120090001354 (Device Identifier: 812345026757) ELI380-DBX32117120557018117120557019117120557020117120557021117230571942117230571943117270577469732094265262S/N: 117120557018, 117120557019, 117120557020, 117120557021, 117230571942, 117230571943, 117270577469 (Device Identifier: 732094265262) ELI380-DCX32118180634420732094265187S/N: 118180634420 (Device Identifier: 732094265187) — 118340001074118340001074118340001075118500001332118460001178119150000120119210000774119290000580119520000194120080001509120080001510120100000310120080001511120110002478120170000570S/N: 118340001074, 118340001074, 118340001075, 118500001332, 118460001178, 119150000120, 119210000774, 119290000580, 119520000194, 120080001509, 120080001510, 120100000310, 120080001511, 120110002478, 120170000570 - Amount recalled
- 27 units
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
Why it was recalled
Devices do not meet IEC 60601-2-27 requirements as labeled.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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