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WELCH ALLYN, INC/MORTARA recalls ELI PC. The ELI PC Service automatically converts resting ECG recordings collected with WAM PC patient cables and WebUpl
Recalled May 6, 2020 · FDA recall Z-1811-2020 · WELCH ALLYN, INC/MORTARA
Hazard
Impacted Welch Allyn products may not meet the Defibrillation Withstand requirements of EN/IEC 60601-2-25 Medical Electrical Equipment. · FDA Class II
Units
78,521 units total
Sold at
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.
Description
Impacted Welch Allyn products may not meet the Defibrillation Withstand requirements of EN/IEC 60601-2-25 Medical Electrical Equipment.
Product
ELI PC. The ELI PC Service automatically converts resting ECG recordings collected with WAM PC patient cables and WebUpload into DICOM 12-lead ECG Waveform files.
Manufacturer(s)
WELCH ALLYN, INC/MORTARA
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →