NxStage System One S Cycler - Model no. NX1000-3-A (OUS). For home hemodialysis.
FDA Recall Z-0336-2016 · Posted None
Recalling FirmNxStage Medical, Inc.
Recall StatusTerminated
Product CodeKDI
Date Initiated2015-10-29
Date Terminated2019-11-19
Product Quantity133 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.