BEUDAMED
    FDA Enforcement Class II Terminated

    ELI 280 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-1482-2021 · Reported April 28, 2021

    Enforcement

    Recall Number
    Z-1482-2021
    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 280 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: ELI280-LDB-ADAAX (Device Identifier: 732094265699); S/N: 117030550918 and 117030550919 Part Number: ELI280-LDD-AAABX (Device Identifier: 732094265682); S/N: 117260576403 Part Number: ELI280-LDX-ADABX (Device Identifier: 732094265675); S/N: 118240001697 and 118150627678 Part Number: ELI280-LDX-ADFBD (Device Identifier: 732094265644); 118230000580, 118230000570, 118230000584, 118230000569, 118230000572 118230000582, 118230000574, 118230000576, 118230000577, 118230000581, 118230000568, 118230000575, 118230000583, 118230000578, 118230000571, 118230000567, 118340001621, 118340001622, 118340001623, 118400001475, 118400001471, 118400001472, 118400001476, 118400001467, 118400001470, 118400001469, 118400001482, 118400001477, 118400001481, 118400001478, 118400001479, 118400001480, 118420000070, 118420000071, 118420000065, 118420000067, 118420000068, 118420000066, 118420000069, 118430000923, 118430000946, 118430000930, 118430000932, 118430000928, 119150000011, 119150000001, 119150000002, 119150000003, 119150000010, 119150000008, 119150000009, 119150000004, 119150000007, 119180000631, 119180000632, 119180000633, 119180001155, 119180001156, 119180001153, 119180001154, 119180001157, 119260000043, 119260000442, 119260000443, 119280001568, 119270000064, 119290001054, 119290001053, 119290001048, 119290001052, 119290001050, 119290001049, 119290001051, 119290001055, 119470001878, 119470001879, 119510000132, 119510000135, 119510000134, 119510000133, 120080000860, 120050001405, 118120622367, 118180633837, 118180633838, 118180633839, 118180633840, 118190635342, 118190635353 Part Number: ELI280-LDX-ADFBG (Device Identifier: 732094319941); S/N: 119480000195, 119480000191, 119480000193, 119480000194, 119480000192

    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

    99 units