FDA-Device2015-12-02Class II
NxStage System One S Cycler (High Permeability Hemodialysis System) Model no. NX1000-5-A
NxStage Medical, Inc.
Hazard
Ultrafiltration (UF) Volume software error inaccurate fluid removal
Sold states
Worldwide Distribution. US Nationwide, Netherlands, and Sweden.
Affected count
16 units
Manufactured in
350 Merrimack Street, N/A, Lawrence, MA, United States
Products
NxStage System One S Cycler (High Permeability Hemodialysis System) Model no. NX1000-5-A
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0327-2016Don't want to check this manually?
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