FDA Medical Device Recalls (openFDA)
NxStage Medical, Inc.: NxStage System One S Cycler (High Permeability Hemodialysis System) Model no. NX1000-5
- Recall number
- Z-0326-2016
- Recalling firm
- NxStage Medical, Inc.
- Product
- NxStage System One S Cycler (High Permeability Hemodialysis System) Model no. NX1000-5
- Status
- Terminated
- Initiated
- 2015-10-29
- Posted
- not on file
- Terminated
- 2019-04-29
- Reason
- Ultrafiltration (UF) Volume software error inaccurate fluid removal
- Root cause
- Software Design Change
- 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).
- Quantity
- 323 units
- Distribution
- Worldwide Distribution. US Nationwide, Netherlands, and Sweden.
- Lot, serial or model codes
- Software versions 4.9 and 4.10
- 510(k) numbers
- ["K133547"]
- 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