FDA Medical Device Recalls (openFDA)
NxStage Medical, Inc.: NxStage System One S Cycler - Model no. NX1000-3-A (OUS). For home hemodialysis.
- Recall number
- Z-0336-2016
- Recalling firm
- NxStage Medical, Inc.
- Product
- NxStage System One S Cycler - Model no. NX1000-3-A (OUS). For home hemodialysis.
- Status
- Terminated
- Initiated
- 2015-10-29
- Posted
- not on file
- Terminated
- 2019-11-19
- Reason
- 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
- Root cause
- Software design
- 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.
- Quantity
- 133 units
- Distribution
- Worldwide Distribution.
- Lot, serial or model codes
- Software version 4.9 and 4.10
- 510(k) numbers
- ["K140526"]
- PMA numbers
- not on file
- Product code
- KDI
- Firm FEI
- 3003464075
- Firm city
- Lawrence
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28