NxStage System One S Cycler Recalled for Ultrafiltration Software Error
NxStage Medical is recalling 323 System One S Cycler units due to a software error that may cause inaccurate fluid removal during hemodialysis.
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 is classified as FDA Class II and involves a risk-of-harm product (hemodialysis system) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
NxStage Medical, Inc. is recalling 323 units of the NxStage System One S Cycler (High Permeability Hemodialysis System), Model no. NX1000-5. The recall involves software versions 4.9 and 4.10. The devices were distributed worldwide, including in the United States, the Netherlands, and Sweden.
The recall was initiated because of an ultrafiltration (UF) volume software error that may result in inaccurate fluid removal. This is a Class II recall, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
Patients and healthcare providers using these devices should contact NxStage Medical for further instructions on how to address the software error. The source text does not report any specific illnesses or injuries associated with this recall.
The recalled product
- Product
- NxStage System One S Cycler (High Permeability Hemodialysis System) Model no. NX1000-5
- Manufacturer
- NxStage Medical, Inc.
- Affected units
- 323
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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