BEUDAMED
    FDA Enforcement Class II Terminated

    v.1.2 Upgrade Kit or v.1.2 upgrade installed on WorkMate Claris System, Model H700123. The WorkMate Claris" System is a computer-based electrocardiographic recording and monitoring system designed for efficient capture, display, and retrieval of surface and intracardiac signals during cardiac EP studies.

    Recall: Z-1853-2021 · Reported June 23, 2021

    Enforcement

    Recall Number
    Z-1853-2021
    Event ID
    87904
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Abbott Laboratories Inc. (St Jude Medical)
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Visit
    Report Date
    June 23, 2021
    Initiation Date
    May 5, 2021
    Classification Date
    June 14, 2021
    Termination Date
    June 18, 2024
    Address
    1 Saint Jude Medical Dr, Saint Paul, MN, 55117-1789, United States

    Description

    v.1.2 Upgrade Kit or v.1.2 upgrade installed on WorkMate Claris System, Model H700123. The WorkMate Claris" System is a computer-based electrocardiographic recording and monitoring system designed for efficient capture, display, and retrieval of surface and intracardiac signals during cardiac EP studies.

    Reason

    Due to a software error, the user may lose functionality of the system or the screen may turn black during operation.

    Code Info

    Serial Numbers: 14399319, 15508962, 18782712, 18855856

    Distribution

    US Nationwide distribution in the states of MI, KS, MO, TX.

    Quantity

    4 units