Medical device recalls Moderate risk

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

Recall date
October 29, 2015
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0327-2016
FDA classification
Class II
Brand / firm
NxStage Medical, Inc.
Sold / distributed
Worldwide Distribution. US Nationwide, Netherlands, and Sweden.

Why it was recalled

Ultrafiltration (UF) Volume software error inaccurate fluid removal

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

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