Recall Z-0327-2016— NxStage Medical, Inc.

Name: FDA recall Z-0327-2016
Creator: U.S. Food and Drug Administration
Published: 2015-10-29

Class II · Terminated

Class II FDA medical device recall by NxStage Medical, Inc., initiated 2015-10-29, terminated 2019-04-29. It names one FDA 510(k) clearance: K133547. Product: NxStage System One S Cycler (High Permeability Hemodialysis System) Model no. NX1000-5-A. Reason: Ultrafiltration (UF) Volume software error inaccurate fluid removal.

Recalling firm: NxStage Medical, Inc.
Classification: Class II
Status: Terminated
Initiated: 2015-10-29
Terminated: 2019-04-29
Firm location: Lawrence, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K133547 — NXSTAGE SYSTEM ONE WITH NXVIEWNxstage Medical, Inc.·cleared 2014-03-03

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

NxStage System One S Cycler (High Permeability Hemodialysis System) Model no. NX1000-5-A

Reason for recall

Ultrafiltration (UF) Volume software error inaccurate fluid removal

Data sourced from openFDA. This site is unofficial and independent of the FDA.