BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-0327-2016 · Initiated October 29, 2015

    Recall

    Recall Number
    Z-0327-2016
    Event Number
    72543
    Firm
    NxStage Medical, Inc.
    FEI Number
    3003464075
    Product Code
    KDI
    Status
    Terminated
    Root Cause
    Software Design Change
    Initiated
    October 29, 2015
    Terminated
    April 29, 2019
    Address
    350 Merrimack Street, Lawrence, MA, 01843-1748

    Description

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

    Reason

    Ultrafiltration (UF) Volume software error inaccurate fluid removal

    Action

    NxStage issued issued a Field Safety Notice (FSN) on 10/29/15 to consignees who have NX1000-5 or a NX1000-5-A cycler. The FSN included Instructions for steps to be taken so that the cycler and treatments are not affected by the software error. NxStage will be sending a representative to the facility to attach detailed instructions on each cycler as a user reference. Return the attached reply form to acknowledge receipt of this letter. Questions or comments, please contact NxStage Customer Service at 1-866-NXSTAGE (1-866-697-8243).

    Distribution

    Worldwide Distribution. US Nationwide, Netherlands, and Sweden.

    Quantity

    16 units