FDA Device recall Z-0337-2016
NxStage System One S Cycler -High Permeability Hemodialysis System Model no
- FDA Device
- Class II
- terminated
- Published 2015-12-02
On 2015-12-02 the FDA classified a Class II recall of NxStage System One S Cycler -High Permeability Hemodialysis System Model no by Nxstage Medical, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0337-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-10-29 |
| Published | 2015-12-02 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Nxstage Medical |
| Distribution | n/a |
Product
NxStage System One S Cycler -High Permeability Hemodialysis System Model no. NX1000-4
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
Identifiers
| code_info | Software version 4.9 and 4.10 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0337-2016%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.