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
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = KDI
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