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NxStage Medical, Inc. recalls NxStage System One S Cycler (High Permeability Hemodialysis System) Model no. NX1000-5
Recalled December 2, 2015 · FDA recall Z-0326-2016 · NxStage Medical
Hazard
Ultrafiltration (UF) Volume software error inaccurate fluid removal · FDA Class II
Units
323 units
Sold at
Worldwide Distribution. US Nationwide, Netherlands, and Sweden.
Description
Ultrafiltration (UF) Volume software error inaccurate fluid removal
Product
NxStage System One S Cycler (High Permeability Hemodialysis System) Model no. NX1000-5
Manufacturer(s)
NxStage Medical, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →