Recall Z-0326-2016 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
NxStage Medical, Inc.
NxStage System One S Cycler (High Permeability Hemodialysis System) Model no. NX1000-5
| Date | Oct 29, 2015 |
| Status | Terminated |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K133547 | NXSTAGE SYSTEM ONE WITH NXVIEW Nxstage Medical, Inc., Mar 3, 2014 |