CLASS II Device recall · Reported 2 Dec 2015 · FDA Enforcement Report

NxStage System One S Cycler (High Permeability Hemodialysis System) recalled

NxStage Medical is recalling NxStage System One S Cycler (High Permeability Hemodialysis System), distributed nationwide in the US. The recall was initiated on 29 Oct 2015 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSoftware versions 4.9 and 4.10

Quantity recalled323 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0326-2016
FDA event ID: 72543
Recalling firm: NxStage Medical, Lawrence, MA
Classification: Class II
Status: Terminated
Recall initiated: 29 Oct 2015
FDA classified: 23 Nov 2015
Reported: 2 Dec 2015
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Labeling Errors
Device type: Other Medical Devices

Timeline

29 Oct 2015	Recall initiated by company
23 Nov 2015	Classified by FDA	+25 days
2 Dec 2015	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Ultrafiltration (UF) Volume software error inaccurate fluid removal

Product as listed by the FDA

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

Where it was distributed

Worldwide Distribution. US Nationwide, Netherlands, and Sweden.

Nationwide

Questions about this recall

Is NxStage System One S Cycler (High Permeability Hemodialysis System) recalled?

Yes. NxStage Medical recalled NxStage System One S Cycler (High Permeability Hemodialysis System) on 29 Oct 2015. The recall is Class II and its status is Terminated. Recall number Z-0326-2016.

Why was it recalled?

Ultrafiltration (UF) Volume software error inaccurate fluid removal

Which lots are affected?

Software versions 4.9 and 4.10

Where was it sold?

Worldwide Distribution. US Nationwide, Netherlands, and Sweden.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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