FDA recall Z-1816-2020

WELCH ALLYN, INC/MORTARA · Class II · device

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

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

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1816-2020