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.
What this means for you
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.
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