Dec

2015

Cl II NxStage System One S Cycler NX1000-4

Company:.NxStage Medical, Inc.
Date of Enforcement Report 12/2/2015
Class lI:

PRODUCT

NxStage System One S Cycler -High Permeability Hemodialysis System Model no. NX1000-4. Recall Number Z-0337-2016

REASON
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

RECALLING FIRM/MANUFACTURER
NxStage Medical, Inc., Lawrence, MA on 10/29/2015. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
7

DISTRIBUTION
Nationwide and Internationally

___________________________________

About the author

Amy Sellers

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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Cl II NxStage System One S Cycler NX1000-4

Amy Sellers

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