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U.S. Department of Health and Human Services

Class 2 Device Recall NxStage System One

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  Class 2 Device Recall NxStage System One see related information
Date Initiated by Firm October 29, 2015
Create Date November 23, 2015
Recall Status1 Terminated 3 on April 29, 2019
Recall Number Z-0327-2016
Recall Event ID 72543
510(K)Number K133547  
Product Classification Dialyzer, high permeability with or without sealed dialysate system - Product Code KDI
Product NxStage System One S Cycler (High Permeability Hemodialysis System)
Model no. NX1000-5-A
Code Information Software versions 4.9 and 4.10 
Recalling Firm/
Manufacturer		 NxStage Medical, Inc.
350 Merrimack Street
Lawrence MA 01843-1748
For Additional Information Contact
978-687-4700
Manufacturer Reason
for Recall		 Ultrafiltration (UF) Volume software error inaccurate fluid removal
FDA Determined
Cause 2		 Software Design Change
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).
Quantity in Commerce 16 units
Distribution Worldwide Distribution. US Nationwide, Netherlands, and Sweden.
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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