FDA-Device2021-04-28Class II
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.
Welch Allyn Inc Mortara
Hazard
Devices do not meet IEC 60601-2-27 requirements as labeled.
Sold states
US Nationwide distribution in the states of CA, CO, FL, GA, IN, LA, NC, NJ, NV, NY, OH, OK, TX, UT, and VA.
Affected count
27 units
Manufactured in
7865 N 86th St, N/A, Milwaukee, WI, United States
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1483-2021Don't want to check this manually?
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