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.

Reason: Devices do not meet IEC 60601-2-27 requirements as labeled.

Code information: Part Number: ELI380-ACX32 (Device Identifier: 732094265415); S/N: 118490001284, 119150000588, 120090001355, 120090001354 Part Number: ELI380-DAX3X (Device Identifier: 812345026757); S/N: 117120557018, 117120557019, 117120557020, 117120557021, 117230571942, 117230571943, 117270577469 Part Number: ELI380-DBX32 (Device Identifier: 732094265262); S/N: 118180634420 Part Number: ELI380-DCX32 (Device Identifier: 732094265187); S/N: 118340001074, 118340001074, 118340001075, 118500001332, 118460001178, 119150000120, 119210000774, 119290000580, 119520000194, 120080001509, 120080001510, 120100000310, 120080001511, 120110002478, 120170000570

Distribution pattern: US Nationwide distribution in the states of CA, CO, FL, GA, IN, LA, NC, NJ, NV, NY, OH, OK, TX, UT, and VA.