# FDA recall Z-1816-2020

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

## Product

Surveyor S12/S19 and patient cable for the S12/S19 Bedside Monitor under the following device names: PAT CBL 10WIRE AHA SNAP JSCREW, PAT CBL 10WIRE IEC SNAP JSCREW.     The Surveyor S12 patient monitor is designed for continuous monitoring in either stationary or portable applications.

## 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-1816-2020
- **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-1816-2020

## Citation

> AI Analytics. FDA recall Z-1816-2020. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1816-2020. Source: US FDA. Licensed CC0.

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