FDA-Device2015-12-02Class II
NxStage System One S Cycler -High Permeability Hemodialysis System Model no. NX1000-4
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
7 units
Manufactured in
350 Merrimack Street, N/A, Lawrence, MA, United States
Products
NxStage System One S Cycler -High Permeability Hemodialysis System Model no. NX1000-4
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0337-2016Don't want to check this manually?
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