NxStage System One S Cycler - Model no. NX1000-3. For home hemodialysis.
- Company
- Nxstage Medical, Inc.
- Recall Initiated
- October 29, 2015
- Terminated
- November 19, 2019
- Recall Number
- Z-0335-2016
- Quantity
- 2,134 units
- Firm Location
- Lawrence, MA
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
Distribution
Worldwide Distribution.
Lot / Code Info
Software version 4.9 and 4.10
Root Cause
Software design
Action Taken
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.