FDA recall Z-1483-2021

Product

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 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.

Key facts

Status

Terminated

Initiation date

2021-03-31

Report date

2021-04-28

Termination date

2024-08-16

Voluntary/Mandated

Voluntary: Firm initiated

Location

Milwaukee, WI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1483-2021