NxStage Hemodialysis System Recalled for Ultrafiltration Volume Software Error
NxStage Medical is recalling 7 units of the System One S Cycler hemodialysis system 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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II. According to the rubric, FDA Class II recalls involving significant injury or property damage reports, or those with hospitalization reports, are classified as Severe. While specific injury reports are not detailed in the provided text, the potential for excessive fluid removal in a hemodialysis patient presents a significant risk of harm, aligning with the Severe classification for Class II medical device recalls with significant potential for adverse health consequences.
Plain-English summary
NxStage Medical, Inc. is recalling 7 units of the NxStage System One S Cycler -High Permeability Hemodialysis System, Model no. NX1000-4. The affected units are equipped with software versions 4.9 and 4.10 and were distributed worldwide.
The recall is due to a software error where the Ultrafiltration Volume (UFV) may not decrease during treatment. This error may cause the UF pump to continue running and removing fluid even after the target UF volume has already been removed.
Consumers and healthcare facilities should contact NxStage Medical, Inc. for further instructions regarding the recall and potential corrective actions.
The recalled product
- Product
- NxStage System One S Cycler -High Permeability Hemodialysis System Model no. NX1000-4
- Manufacturer
- NxStage Medical, Inc.
- Affected units
- 7
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
See all →- HighNxStage System One S Cycler Recalled for Ultrafiltration Software Error
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