BEUDAMED
    FDA Enforcement Class II Terminated

    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.

    Recall: Z-1811-2020 · Reported May 6, 2020

    Enforcement

    Recall Number
    Z-1811-2020
    Event ID
    85297
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    WELCH ALLYN, INC/MORTARA
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 6, 2020
    Initiation Date
    March 18, 2020
    Classification Date
    April 29, 2020
    Termination Date
    February 9, 2026
    Address
    7865 N 86th St, N/A, Milwaukee, WI, 53224-3431, United States

    Description

    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.

    Reason

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

    Code Info

    Model Numbers: 11066-XXX-50, 41000-029-XX.

    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.

    Quantity

    78,521 units total