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U.S. Department of Health and Human Services

Class 2 Device Recall NxStage

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  Class 2 Device Recall NxStage see related information
Date Initiated by Firm October 29, 2015
Create Date November 25, 2015
Recall Status1 Terminated 3 on November 19, 2019
Recall Number Z-0335-2016
Recall Event ID 72554
510(K)Number K122051  
Product Classification Dialyzer, high permeability with or without sealed dialysate system - Product Code KDI
Product NxStage System One S Cycler - Model no. NX1000-3.

For home hemodialysis.
Code Information Software version 4.9 and 4.10
Recalling Firm/
Manufacturer
NxStage Medical, Inc.
350 Merrimack Street
Lawrence MA 01843-1748
For Additional Information Contact SAME
978-687-4700
Manufacturer Reason
for Recall
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
FDA Determined
Cause 2
Software design
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.
Quantity in Commerce 2,134 units
Distribution Worldwide Distribution.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = KDI and Original Applicant = NXSTAGE MEDICAL, INC.
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