NxStage System One S Cycler Recalled for Ultrafiltration Software Error
NxStage Medical is recalling 133 System One S Cycler units due to a software error that may cause the pump to continue removing fluid after the target volume is reached.
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 software error that poses a risk of harm (excessive fluid removal) to patients, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
NxStage Medical, Inc. is recalling 133 units of the NxStage System One S Cycler (Model no. NX1000-3-A) used for home hemodialysis. The recall involves software versions 4.9 and 4.10.
The recall is due to a software error where the Ultrafiltration Volume (UFV) may not decrease during treatment. This error can cause the UF pump to continue running and removing fluid even after the target UF volume has already been removed.
The affected units were distributed worldwide. Consumers using these devices should contact NxStage Medical for further instructions on how to address the software error.
The recalled product
- Product
- NxStage System One S Cycler - Model no. NX1000-3-A (OUS). For home hemodialysis.
- Manufacturer
- NxStage Medical, Inc.
- Affected units
- 133
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 version 4.9 and 4.10
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 3 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.
See all 3 products in this recall →Related recalls
Same manufacturer · NxStage Medical, Inc.
See all →- HighNxStage PureFlow-B Solution Bags Perimeter Seal Failure Risk
FDA (Devices) · 2025-06-04
- HighNxStage PureFlow-B Hemodialysis Solution Bags Recalled Due to Bursting Chambers and Caustic Fluid
FDA (Devices) · 2024-06-26
- HighNxStage Low Volume Cartridge Recalled for Hemodialysis Risk
FDA (Devices) · 2019-12-25
- ModerateNxStage PureFlow B Solution Recalled for Incorrect Product Number Labeling
FDA (Devices) · 2019-06-12
- ModerateNxStage PureFlow B Solution Recalled for Incorrect Product Number Labeling
FDA (Devices) · 2019-06-12
Same hazard · software error
See all →- ModerateBeckman Coulter DxC 500 AU Clinical Chemistry Analyzers Recalled for Software Error
FDA (Devices) · 2026-10-14
- HighPhilips Spectral CT 7500 Software Recall for Radiation Exposure Risk
FDA (Devices) · 2026-10-07
- HighBard EnCor EnCompass Breast Biopsy System Software Recall
FDA (Devices) · 2026-10-07
- ModerateBeckman Coulter AU480 Chemistry Analyzer Software Error Recall
FDA (Devices) · 2026-10-07
- HighPhilips EPIQ Elite Ultrasound System Recalled for Software Error
FDA (Devices) · 2026-09-30
Similar recalls
- HighNxStage System One S Cycler Recalled for Ultrafiltration Software Error
FDA (Devices) · 2015-12-02
- HighNxStage Low Volume Cartridge Recalled for Hemodialysis Risk
FDA (Devices) · 2019-12-25
- HighNxStage PureFlow B Solution Recalled for Missing Labeling Warnings
FDA (Devices) · 2018-03-28
- ModerateNxStage PureFlow-B Solution Recalled for Potential Mislabeled Product
FDA (Devices) · 2013-05-08
- ModerateNxStage PureFlow B Solution Recalled for Incorrect Product Number Labeling
FDA (Devices) · 2019-06-12
- SevereFresenius 2008T Hemodialysis System Recalled for Software Error
FDA (Devices) · 2017-01-25