FDA-Device2015-12-02Class II
NxStage System One S Cycler - Model no. NX1000-3. For home hemodialysis.
NxStage Medical, Inc.
Hazard
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
Sold states
Worldwide Distribution.
Affected count
2,134 units
Manufactured in
350 Merrimack Street, N/A, Lawrence, MA, United States
Products
NxStage System One S Cycler - Model no. NX1000-3. For home hemodialysis.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0335-2016Don't want to check this manually?
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