NxStage System One S Cycler (High Permeability Hemodialysis System) Model no. NX1000-5
- Company
- Nxstage Medical, Inc.
- Recall Initiated
- October 29, 2015
- Terminated
- April 29, 2019
- Recall Number
- Z-0326-2016
- Quantity
- 323 units
- Firm Location
- Lawrence, MA
Reason for Recall
Ultrafiltration (UF) Volume software error inaccurate fluid removal
Distribution
Worldwide Distribution. US Nationwide, Netherlands, and Sweden.
Lot / Code Info
Software versions 4.9 and 4.10
Root Cause
Software Design Change
Action Taken
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).
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