Product Wiki · Recalls · U.S. FDA — Device Enforcement

NxStage System One S Cycler -High Permeability Hemodialysis System… — recall Z-0337-2016

U.S. FDA — Device Enforcement · United States · 2015-10-29 · Class II

As described by U.S. FDA — Device Enforcement: NxStage System One S Cycler -High Permeability Hemodialysis System Model no. NX1000-4

Compiled from an official source — the facts on this page are reproduced from the issuing authority’s own published notice, which is linked above. No AI-generated text appears on this page. How we use AI →
Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0337-2016
Date of alert
2015-10-29
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
NxStage Medical, Inc.
Product category
device
Product type
Devices
Recall status
Terminated — the recall action is complete and the FDA has closed it
Initiated by
Voluntary: Firm initiated
Distribution
Worldwide Distribution.
Reported risk: 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
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

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