# FDA recall Z-0553-2021

> **WELCH ALLYN, INC/MORTARA** · Class II · device recall initiated 2020-11-11.

## Product

ELI 380 Electrocardiograph - Product Usage: intended to be a high-performance, multichannel resting electrocardiograph. As a resting electrocardiograph, the ELI 380 simultaneously acquires data from each lead.

## Reason for recall

The radio within the device can become disassociated with the wireless access point.

## Distribution

Worldwide distribution - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, FL, GA, HI, IN, KS, KY, MA, MD, MI, MO, MT, NC, ND, NH, NM, NV, NY, OH, OR, PA, SC, SD, TN, TX, UT, WA, WI, WV, WY and the countries of  Australia, Canada, Czech, Finland, GB, Germany, Italy, Kuwait, Netherlands, New Zealand, Norway, Qatar, Switzerland, United Arab Emirates, United Kingdom.

## Key facts

- **Recall number:** Z-0553-2021
- **Recalling firm:** WELCH ALLYN, INC/MORTARA
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-11-11
- **Report date:** 2020-12-16
- **Termination date:** 2023-08-08

- **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-0553-2021

## Citation

> AI Analytics. FDA recall Z-0553-2021. Retrieved 2026-07-27 from https://api.ai-analytics.org/recall/Z-0553-2021. Source: US FDA. Licensed CC0.

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