Date Initiated by Firm | October 29, 2015 |
Create Date | November 25, 2015 |
Recall Status1 |
Terminated 3 on November 19, 2019 |
Recall Number | Z-0336-2016 |
Recall Event ID |
72554 |
510(K)Number | K140526 |
Product Classification |
Dialyzer, high permeability with or without sealed dialysate system - Product Code KDI
|
Product | NxStage System One S Cycler - Model no. NX1000-3-A (OUS).
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 | 133 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
|