BEUDAMED
    FDA Recall 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 · Initiated March 31, 2021

    Recall

    Recall Number
    Z-1483-2021
    Event Number
    87686
    Firm
    Welch Allyn Inc Mortara
    FEI Number
    2183461
    Product Code
    DPS
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    March 31, 2021
    Terminated
    August 16, 2024
    Address
    7865 N 86th St, Milwaukee, WI, 53224-3431

    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.

    Action

    Recall notification letters were mailed to customers notifying them of the potential issue with recommended actions beginning April 7, 2021. The notification letter includes an acknowledgement form that must be returned to the recalling firm. Once the customer confirms the impacted units are in possession, the recalling firm will arrange for an exchange AM12M to be provided. The recalled unit will be returned to the recalling firm's service center for processing.

    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