NxStage System One S Cycler recall: Software Issue
NxStage System One S Cycler - Model no. NX1000-3-A (OUS). For home hemodialysis.
Why was NxStage System One S Cycler recalled?
Ultrafiltration Volume (UFV) may not decrease during treatment-software error. The UF pump may continue to run and remove fluid even after the target UF volume has been removed
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Software version 4.9 and 4.10
- Product
- NxStage System One S Cycler - Model no. NX1000-3-A (OUS). For home hemodialysis.
- Recalling firm
- NxStage Medical, Inc.
- Quantity
- 133 units
- Distribution
- Worldwide Distribution.
- Recall date
- December 2, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)