# FDA recall Z-1813-2020

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

## Product

T12. Incorporates wireless electrocardiographic technology to achieve the real-time acquisition and RF transmission of simultaneous 12-lead ECG data with diagnostic quality while allowing the patient to be ambulatory.

## 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-1813-2020
- **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-1813-2020

## Citation

> AI Analytics. FDA recall Z-1813-2020. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1813-2020. Source: US FDA. Licensed CC0.

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