NxStage Medical, Inc.: Medical Device Recall in 2015 - (Recall #: Z-0326-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: October 29, 2015

Date Posted: December 2, 2015

Recall Number: Z-0326-2016

Event ID: 72543

Reason for Recall:

Ultrafiltration (UF) Volume software error inaccurate fluid removal

Status: Terminated

Product Quantity: 323 units

Code Information:

Software versions 4.9 and 4.10

Distribution Pattern:

Worldwide Distribution. US Nationwide, Netherlands, and Sweden.

Voluntary or Mandated:

Voluntary: Firm initiated