# FDA recall Z-1810-2020

> **WELCH ALLYN, INC/MORTARA** · Class II · device recall initiated 2020-03-18.

## Product

Lead diagnostic electrocardiograph under the following device names: ELI 10, ELI 350, ELI 150c, ELI 250c, ELI 230, ELI 280, ELI 380, R-Scribe and Connex Cardio.      Product Usage: A non-invasive prescription device indicated for use to acquire, analyze, display, transmit and print electrocardiograms.

## Reason for recall

Impacted Welch Allyn products may not meet the  Defibrillation Withstand  requirements of EN/IEC 60601-2-25 Medical Electrical Equipment.

## Distribution

US nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, ON, OR, PA, PR, RI, SC, SD, TN,UT, VA, VT, WA, WI, WV and WY.

## Key facts

- **Recall number:** Z-1810-2020
- **Recalling firm:** WELCH ALLYN, INC/MORTARA
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-03-18
- **Report date:** 2020-05-06
- **Termination date:** 2026-02-09

- **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-1810-2020

## Citation

> AI Analytics. FDA recall Z-1810-2020. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-1810-2020. Source: US FDA. Licensed CC0.

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