Z-0336-2016Class II

NxStage System One S Cycler - Model no. NX1000-3-A (OUS). For home hemodialysis

Name: Z-0336-2016 NxStage System One S Cycler - Model no. NX1000-3-A (OUS). For home hemodialysis
Creator: NxStage Medical, Inc.
Published: 2015-10-29
License: https://open.fda.gov/license/

NxStage Medical Inc / initiated 2015-10-29 / Terminated / root cause: software

FDA source

NxStage Medical, Inc. began a recall of NxStage System One S Cycler - Model no. NX1000-3-A (OUS). For home hemodialysis on 2015-10-29. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0336-2016
Classification: Class II
Status: Terminated
Initiated: 2015-10-29
Posted: 2015-11-25
Terminated: 2019-11-19
Recalling firm: NxStage Medical Inc
Product: NxStage System One S Cycler - Model no. NX1000-3-A (OUS). For home hemodialysis.
Product code: KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
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
Root cause tag: software
FDA root cause: 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.
Product codes and lots: Software version 4.9 and 4.10

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0336-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0335-2016	Class II	Terminated	Voluntary: Firm initiated	2015-12-02	2015-11-25
Z-0336-2016	Class II	Terminated	Voluntary: Firm initiated	2015-12-02	2015-11-25
Z-0337-2016	Class II	Terminated	Voluntary: Firm initiated	2015-12-02	2015-11-25

Product code KDI

K140526Class IINxstage System OneNxstage Medical, Inc. / cleared 2014-05-19

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)