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Welch Allyn Inc Mortara recalls ELI 280 Electrocardiograph, with AM12M Acquisition Module accessory. Impacted software version of the AM12M is version
Recalled April 28, 2021 · FDA recall Z-1482-2021 · Welch Allyn Inc Mortara
Hazard
Devices do not meet IEC 60601-2-27 requirements as labeled. · FDA Class II
Units
99 units
Sold at
US Nationwide distribution in the states of CA, CO, FL, GA, IN, LA, NC, NJ, NV, NY, OH, OK, TX, UT, and VA.
Description
Devices do not meet IEC 60601-2-27 requirements as labeled.
Product
ELI 280 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.
Manufacturer(s)
Welch Allyn Inc Mortara
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →