FDA-Device2020-05-06Class II
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.
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.
Sold states
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.
Affected count
78,521 units total
Manufactured in
7865 N 86th St, N/A, Milwaukee, WI, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1811-2020Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief