BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-0336-2016 · Initiated October 29, 2015

    Recall

    Recall Number
    Z-0336-2016
    Event Number
    72554
    Firm
    NxStage Medical, Inc.
    FEI Number
    3003464075
    Product Code
    KDI
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    October 29, 2015
    Terminated
    November 19, 2019
    Address
    350 Merrimack Street, Lawrence, MA, 01843-1748

    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

    Action

    NxStage issued a Field Safety Notice (FSN), dated October 29, 2015, to clinic and home patients with a NX1000-3 or NX1000-4 cycler. For patients performing short daily hemodialysis, the FSN included instructions for steps to be taken so that the cycler and treatments are not affected by the software error. Patients performing nocturnal hemodialysis were instructed to contact their Center for a replacement NX1000-1 Cycler. A software update will be released to correct the error. Customers should complete and return the reply form. Contact NxStage Customer Service at 1-866-NXSTAGE (1-866-697-8243) with questions or comments.

    Distribution

    Worldwide Distribution.

    Quantity

    133 units