NxStage System One S Cycler recall: Software Issue
NxStage System One S Cycler (High Permeability Hemodialysis System) Model no. NX1000-5-A
Why was NxStage System One S Cycler recalled?
Ultrafiltration (UF) Volume software error inaccurate fluid removal
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 versions 4.9 and 4.10
- Product
- NxStage System One S Cycler (High Permeability Hemodialysis System) Model no. NX1000-5-A
- Recalling firm
- NxStage Medical, Inc.
- Quantity
- 16 units
- Distribution
- Worldwide Distribution. US Nationwide, Netherlands, and Sweden.
- Recall date
- December 2, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)