Z-0327-2016Class II

NxStage System One S Cycler (High Permeability Hemodialysis System) Model no. NX1000-5-A

Name: Z-0327-2016 NxStage System One S Cycler (High Permeability Hemodialysis System) Model no. NX1000-5-A
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 (High Permeability Hemodialysis System) Model no. NX1000-5-A on 2015-10-29. FDA classified it as Class II and gives the reason as "Ultrafiltration (UF) Volume software error inaccurate fluid removal". 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-0327-2016
Classification: Class II
Status: Terminated
Initiated: 2015-10-29
Posted: 2015-11-23
Terminated: 2019-04-29
Recalling firm: NxStage Medical Inc
Product: NxStage System One S Cycler (High Permeability Hemodialysis System) Model no. NX1000-5-A
Product code: KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Reason for recall: Ultrafiltration (UF) Volume software error inaccurate fluid removal
Root cause tag: software
FDA root cause: 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.
Product codes and lots: Software versions 4.9 and 4.10

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0327-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0326-2016	Class II	Terminated	Voluntary: Firm initiated	2015-12-02	2015-11-23
Z-0327-2016	Class II	Terminated	Voluntary: Firm initiated	2015-12-02	2015-11-23

Product code KDI

K133547Class IINxstage System One with NxviewNxstage Medical, Inc. / cleared 2014-03-03

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)