# FDA recall Z-1815-2020

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

## Product

S4 and patient cable for the S4 Wireless Telemeter with the following device names: CABLE 10 WIRE LF ECG SNAP ENDS AHA GRAY, CABLE 10 WIRE LF ECG SNAP ENDS IEC GRAY, CBL 10WIRE LF LRG ECG SNAP ENDS AHA GRAY, CBL 10WIRE LF LRG ECG SNAP ENDS IEC GRAY.     The S4 mobile monitor provides a means to acquire and transmit simultaneous ECG and SpO2 data to a Surveyor Central Station monitoring system while allowing the patient to be ambulatory within the range of the WiFi network.

## 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-1815-2020
- **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-1815-2020

## Citation

> AI Analytics. FDA recall Z-1815-2020. Retrieved 2026-05-26 from https://api.ai-analytics.org/recall/Z-1815-2020. Source: US FDA. Licensed CC0.

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