WELCH ALLYN, INC/MORTARA recalls ELI PC. The ELI PC Service automatically converts resting ECG recordings collected with WAM PC patient cables and WebUp…

Recall date

March 18, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1811-2020

FDA classification

Class II

Brand / firm

WELCH ALLYN, INC/MORTARA

Sold / distributed

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.

Why it was recalled

Impacted Welch Allyn products may not meet the Defibrillation Withstand requirements of EN/IEC 60601-2-25 Medical Electrical Equipment.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.