NxStage System One S Cycler Recalled for Ultrafiltration Software Error
NxStage Medical is recalling 16 System One S Cycler units due to a software error causing inaccurate fluid removal.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a functional defect (inaccurate fluid removal) that poses a risk of harm, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
NxStage Medical, Inc. is recalling 16 units of the NxStage System One S Cycler (High Permeability Hemodialysis System), Model no. NX1000-5-A. The recall involves software versions 4.9 and 4.10.
The recall is being conducted because of an ultrafiltration (UF) volume software error that results in inaccurate fluid removal. This device is used for high permeability hemodialysis.
The affected units were distributed worldwide, including in the United States, the Netherlands, and Sweden. Users of these specific software versions should contact NxStage Medical for instructions on how to address the software error.
The recalled product
- Product
- NxStage System One S Cycler (High Permeability Hemodialysis System) Model no. NX1000-5-A
- Manufacturer
- NxStage Medical, Inc.
- Category
- Medical Device — Dialysis System
- Affected units
- 16
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Software versions 4.9 and 4.10
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by NxStage Medical, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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