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.
Check against the official notice below — it lists the full affected range.
Welch Allyn Inc is recalling the Mortara ELI 380 Electrocardiograph with AM12M Acquisition Module accessory (software version 1.5.1) because the devices do not meet IEC 60601-2-27 requirements as labeled. The recall affects 27 units that were distributed nationwide across California, Colorado, Florida, Georgia, Indiana, Louisiana, North Carolina, New Jersey, Nevada, New York, Ohio, Oklahoma, Texas, Utah, and Virginia. Specific affected units are identified by part numbers ELI380-ACX32, ELI380-DAX3X, ELI380-DBX32, and ELI380-DCX32, with individual serial numbers listed for each.
The recall record does not specify a remedy or what affected consumers should do with their devices.
Written by software from the official notice below. Not reviewed by a lawyer.
Devices do not meet IEC 60601-2-27 requirements as labeled.
Reason for recall: Devices do not meet IEC 60601-2-27 requirements as labeled. Distribution: US Nationwide distribution in the states of CA, CO, FL, GA, IN, LA, NC, NJ, NV, NY, OH, OK, TX, UT, and VA. Quantity: 27 units Lot/code info: 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
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.