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Terminated

NxStage System One S Cycler -High Permeability Hemodialysis System Model no. NX1000-4

FDA Recall Z-0337-2016 · Posted None

Recalling FirmNxStage Medical, Inc.
Recall StatusTerminated
Product CodeKDI
Date Initiated2015-10-29
Date Terminated2019-11-19
Product Quantity7 units

Reason for Recall

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

Firm Action

NxStage issued a Field Safety Notice (FSN), dated October 29, 2015, to clinic and home patients with a NX1000-3 or NX1000-4 cycler. For patients performing short daily hemodialysis, the FSN included instructions for steps to be taken so that the cycler and treatments are not affected by the software error. Patients performing nocturnal hemodialysis were instructed to contact their Center for a replacement NX1000-1 Cycler. A software update will be released to correct the error. Customers should complete and return the reply form. Contact NxStage Customer Service at 1-866-NXSTAGE (1-866-697-8243) with questions or comments.

Root Cause

Software design

Distribution Pattern

Worldwide Distribution.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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