Welch Allyn Inc Mortara recalls ELI 380 Electrocardiograph, with AM12M Acquisition Module accessory. Impacted software version of the AM12M is version…
- Recall date
- March 31, 2021
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-1483-2021
- FDA classification
- Class II
- Brand / firm
- Welch Allyn Inc Mortara
- Sold / distributed
- US Nationwide distribution in the states of CA, CO, FL, GA, IN, LA, NC, NJ, NV, NY, OH, OK, TX, UT, and VA.
Why it was recalled
Devices do not meet IEC 60601-2-27 requirements as labeled.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
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.
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