BEUDAMED
    FDA Enforcement Class II Terminated

    ELI 380 Electrocardiograph - Product Usage: intended to be a high-performance, multichannel resting electrocardiograph. As a resting electrocardiograph, the ELI 380 simultaneously acquires data from each lead.

    Recall: Z-0553-2021 · Reported December 16, 2020

    Enforcement

    Recall Number
    Z-0553-2021
    Event ID
    86716
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    WELCH ALLYN, INC/MORTARA
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 16, 2020
    Initiation Date
    November 11, 2020
    Classification Date
    December 9, 2020
    Termination Date
    August 8, 2023
    Address
    7865 N 86th St, N/A, Milwaukee, WI, 53224-3431, United States

    Description

    ELI 380 Electrocardiograph - Product Usage: intended to be a high-performance, multichannel resting electrocardiograph. As a resting electrocardiograph, the ELI 380 simultaneously acquires data from each lead.

    Reason

    The radio within the device can become disassociated with the wireless access point.

    Code Info

    Part Number Device Identifier ELI380-ABS12 00732094265545 ELI380-ABX12 00732094265514 ELI380-ACQ12 00732094319439 ELI380-ACS11 00812345026313 ELI380-ACX11 00812345024531 ELI380-ACX12 00732094265439 ELI380-ACX21 00812345024562 ELI380-ACX22 00732094265422 ELI380-ACX32 00732094265415 ELI380-DAS44 00732094265354 ELI380-DBX12 00732094265286 ELI380-DBX22 00732094265279 ELI380-DCP12 00732094301670 ELI380-DCQ11 00732094307870 ELI380-DCS11 00812345026917 ELI380-DCS12 00732094265248 ELI380-DCS21 00812345026924 ELI380-DCS43 00812345026948 ELI380-DCT12 00732094265217 ELI380-DCX11 00812345026979 ELI380-DCX12 00732094265200 ELI380-DCX21 00812345026986 ELI380-DCX22 00732094265194 ELI380-DCX32 00732094265187 ELI380-DCX43 00812345027006

    Distribution

    Worldwide distribution - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, FL, GA, HI, IN, KS, KY, MA, MD, MI, MO, MT, NC, ND, NH, NM, NV, NY, OH, OR, PA, SC, SD, TN, TX, UT, WA, WI, WV, WY and the countries of Australia, Canada, Czech, Finland, GB, Germany, Italy, Kuwait, Netherlands, New Zealand, Norway, Qatar, Switzerland, United Arab Emirates, United Kingdom.

    Quantity

    1,009 units