BEUDAMED
    FDA Enforcement Class II Terminated

    NxStage System One S Cycler - Model no. NX1000-3-A (OUS). For home hemodialysis.

    Recall: Z-0336-2016 · Reported December 2, 2015

    Enforcement

    Recall Number
    Z-0336-2016
    Event ID
    72554
    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 25, 2015
    Termination Date
    November 19, 2019
    Address
    350 Merrimack Street, N/A, Lawrence, MA, 01843-1748, United States

    Description

    NxStage System One S Cycler - Model no. NX1000-3-A (OUS). For home hemodialysis.

    Reason

    Ultrafiltration Volume (UFV) may not decrease during treatment-software error. The UF pump may continue to run and remove fluid even after the target UF volume has been removed

    Code Info

    Software version 4.9 and 4.10

    Distribution

    Worldwide Distribution.

    Quantity

    133 units