Home / Recalls / Medical Devices
NxStage Medical, Inc. recalls NxStage System One S Cycler -High Permeability Hemodialysis System Model no. NX1000-4
Recalled December 2, 2015 · FDA recall Z-0337-2016 · NxStage Medical
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 · FDA Class II
Units
7 units
Sold at
Worldwide Distribution.
Description
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
Product
NxStage System One S Cycler -High Permeability Hemodialysis System Model no. NX1000-4
Manufacturer(s)
NxStage Medical, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →