BEUDAMED
    FDA Enforcement Class II Terminated

    2008T, Hemodialysis Delivery System Product Indicated for acute and chronic dialysis therapy.

    Recall: Z-0829-2018 · Reported March 7, 2018

    Enforcement

    Recall Number
    Z-0829-2018
    Event ID
    79239
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Fresenius Medical Care Renal Therapies Group, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    March 7, 2018
    Initiation Date
    October 5, 2017
    Classification Date
    March 1, 2018
    Termination Date
    July 28, 2021
    Address
    920 Winter St, N/A, Waltham, MA, 02451-1521, United States

    Description

    2008T, Hemodialysis Delivery System Product Indicated for acute and chronic dialysis therapy.

    Reason

    While reviewing documentation for the next software release of the 2008T, an R&D technician identified that setting the UF goal to '0' introduces a discrepancy between the UF rate displayed and the actual UF pump rate. The software anomaly is also applicable to the 2008T Machines that contained the 2.63 Bug Fix per DCAF 17-088. 2008T Upgrade kits that contained the 2.63 Bug Fix are also affected. Additionally, SW version 2.64 (in design freeze) is also impacted by this anomaly.

    Code Info

    2008T machines: 190766 2008T Hemodialysis System w/Bibag 190895 2008T GEN 2 Bibag without CDX 190766 = 00840861100910 (+Serial Number) 190895 = 00840861100927 (+Serial Number)ux=&Su

    Distribution

    US Nationwide Distribution

    Quantity

    15 machines