BEUDAMED
    FDA Enforcement Class II Terminated

    ELI 380 Electrocardiograph, with AM12M Acquisition Module accessory. Impacted software version of the AM12M is version 1.5.1 - Product Usage: indicated for use on adult and pediatric populations.

    Recall: Z-1483-2021 · Reported April 28, 2021

    Enforcement

    Recall Number
    Z-1483-2021
    Event ID
    87686
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Welch Allyn Inc Mortara
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 28, 2021
    Initiation Date
    March 31, 2021
    Classification Date
    April 22, 2021
    Termination Date
    August 16, 2024
    Address
    7865 N 86th St, N/A, Milwaukee, WI, 53224-3431, United States

    Description

    ELI 380 Electrocardiograph, with AM12M Acquisition Module accessory. Impacted software version of the AM12M is version 1.5.1 - Product Usage: indicated for use on adult and pediatric populations.

    Reason

    Devices do not meet IEC 60601-2-27 requirements as labeled.

    Code Info

    Part Number: ELI380-ACX32 (Device Identifier: 732094265415); S/N: 118490001284, 119150000588, 120090001355, 120090001354 Part Number: ELI380-DAX3X (Device Identifier: 812345026757); S/N: 117120557018, 117120557019, 117120557020, 117120557021, 117230571942, 117230571943, 117270577469 Part Number: ELI380-DBX32 (Device Identifier: 732094265262); S/N: 118180634420 Part Number: ELI380-DCX32 (Device Identifier: 732094265187); S/N: 118340001074, 118340001074, 118340001075, 118500001332, 118460001178, 119150000120, 119210000774, 119290000580, 119520000194, 120080001509, 120080001510, 120100000310, 120080001511, 120110002478, 120170000570

    Distribution

    US Nationwide distribution in the states of CA, CO, FL, GA, IN, LA, NC, NJ, NV, NY, OH, OK, TX, UT, and VA.

    Quantity

    27 units