BEUDAMED
    FDA Enforcement Class II Terminated

    NxStage System One S Cycler (High Permeability Hemodialysis System) Model no. NX1000-5

    Recall: Z-0326-2016 · Reported December 2, 2015

    Enforcement

    Recall Number
    Z-0326-2016
    Event ID
    72543
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    NxStage Medical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 2, 2015
    Initiation Date
    October 29, 2015
    Classification Date
    November 23, 2015
    Termination Date
    April 29, 2019
    Address
    350 Merrimack Street, N/A, Lawrence, MA, 01843-1748, United States

    Description

    NxStage System One S Cycler (High Permeability Hemodialysis System) Model no. NX1000-5

    Reason

    Ultrafiltration (UF) Volume software error inaccurate fluid removal

    Code Info

    Software versions 4.9 and 4.10

    Distribution

    Worldwide Distribution. US Nationwide, Netherlands, and Sweden.

    Quantity

    323 units