BEUDAMED
    FDA Recall Terminated

    Fresenius 2008K Series : Hemodialysis System

    Recall: Z-1027-2017 · Initiated December 21, 2016

    Recall

    Recall Number
    Z-1027-2017
    Event Number
    76037
    Firm
    Fresenius Medical Care Renal Therapies Group, LLC
    FEI Number
    3001451489
    Product Code
    KDI
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    December 21, 2016
    Terminated
    March 17, 2023
    Address
    920 Winter St, Waltham, MA, 02451-1521

    Description

    Fresenius 2008K 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

    Action

    Fresenius issued Customer Notification via Certified Mail on 12/21/2016. Users provided with problem and recommendation, when adjusting the UF Rate, UF Goal, or Tx Time, is to use the numeric data entry keys instead of the up or down arrow keys. Change the values by using data entry keys, then save by pressing CONFIRM. Fresenius will make arrangements to install software on the hemodialysis machine. Confirmation of the noticed by the consignee will be required via a Reply Form.

    Distribution

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

    Quantity

    78481 (US) 2734 units (OUS)