BEUDAMED
    FDA Enforcement Class II Terminated

    Fresenius 2008T Series Hemodialysis System

    Recall: Z-1026-2017 · Reported January 25, 2017

    Enforcement

    Recall Number
    Z-1026-2017
    Event ID
    76037
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Fresenius Medical Care Renal Therapies Group, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 25, 2017
    Initiation Date
    December 21, 2016
    Classification Date
    January 13, 2017
    Termination Date
    March 17, 2023
    Address
    920 Winter St, Waltham, MA, 02451-1521, United States

    Description

    Fresenius 2008T Series Hemodialysis System

    Reason

    When the UF Rate, Goal or Time is adjusted using the up and down arrow keys, and the change is cancelled by using the esc key, the cancelled UF Rate is actually being executed rather than rate displayed on the machine

    Code Info

    All serial numbers

    Distribution

    Nationwide Foreign: Canada, Mexico, Jamaica, Germany, Guam

    Quantity

    65361 units (US) 249 units (OUS)