# FDA recall Z-1483-2021

> **Welch Allyn Inc Mortara** · Class II · device recall initiated 2021-03-31.

## 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

- **Recall number:** Z-1483-2021
- **Recalling firm:** Welch Allyn Inc Mortara
- **Classification:** Class II
- **Product type:** device
- **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

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

## Citation

> AI Analytics. FDA recall Z-1483-2021. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1483-2021. Source: US FDA. Licensed CC0.

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