Recall Z-0336-2016 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
NxStage Medical, Inc.
NxStage System One S Cycler - Model no. NX1000-3-A (OUS). For home hemodialysis.
| Date | Oct 29, 2015 |
| Status | Terminated |
| 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 (1-866-69 |
| Quantity | 133 units |
| Distribution | Worldwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K140526 | NXSTAGE SYSTEM ONE Nxstage Medical, Inc., May 19, 2014 |