NxStage System One S Cycler (High Permeability Hemodialysis System) Model no. NX1000-5
FDA Recall Z-0326-2016 · Posted None
Recalling FirmNxStage Medical, Inc.
Recall StatusTerminated
Product CodeKDI
Date Initiated2015-10-29
Date Terminated2019-04-29
Product Quantity323 units
Reason for Recall
Ultrafiltration (UF) Volume software error inaccurate fluid removal
Firm Action
NxStage issued issued a Field Safety Notice (FSN) on 10/29/15 to consignees who have NX1000-5 or a NX1000-5-A cycler. The FSN included Instructions for steps to be taken so that the cycler and treatments are not affected by the software error.
NxStage will be sending a representative to the facility to attach detailed instructions on each cycler as a user reference. Return the attached reply form to acknowledge receipt of this letter.
Questions or comments, please contact NxStage Customer Service at 1-866-NXSTAGE (1-866-697-8243).
Root Cause
Software Design Change
Distribution Pattern
Worldwide Distribution. US Nationwide, Netherlands, and Sweden.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.