NxStage Medical, Inc. recalls NxStage System One S Cycler -High Permeability Hemodialysis System Model no. NX1000-4
- Recall date
- October 29, 2015
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-0337-2016
- FDA classification
- Class II
- Brand / firm
- NxStage Medical, Inc.
- Sold / distributed
- Worldwide Distribution.
Why it was recalled
Ultrafiltration Volume (UFV) may not decrease during treatment-software error. The UF pump may continue to run and remove fluid even after the target UF volume has been removed
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. NX1000-4
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