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Terminated

NxStage System One S Cycler (High Permeability Hemodialysis System) Model no. NX1000-5-A

FDA Recall Z-0327-2016 · Posted None

Recalling FirmNxStage Medical, Inc.
Recall StatusTerminated
Product CodeKDI
Date Initiated2015-10-29
Date Terminated2019-04-29
Product Quantity16 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.

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