NxStage System One S Cycler Recalled for Ultrafiltration Software Error
NxStage Medical is recalling 2,134 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 high-risk medical device where a software error could lead to excessive fluid removal, posing a risk of harm, but the source text does not report any specific injuries or illnesses.
Plain-English summary
NxStage Medical, Inc. is recalling 2,134 units of the NxStage System One S Cycler (Model no. NX1000-3) used for home hemodialysis. The recall involves units running software versions 4.9 and 4.10, which were distributed worldwide.
The recall is due to a software error that may prevent the Ultrafiltration Volume (UFV) from decreasing during treatment. As a result, the UF pump may continue to run and remove fluid even after the target UF volume has already been removed.
Patients using these devices for home hemodialysis should contact NxStage Medical or their healthcare provider for instructions on how to proceed. The source text does not specify a date for the recall or report any specific injuries or illnesses.
The recalled product
- Product
- NxStage System One S Cycler - Model no. NX1000-3. For home hemodialysis.
- Manufacturer
- NxStage Medical, Inc.
- Affected units
- 2,134
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
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Same hazard · excessive fluid removal
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