FDAFDA · Food and drugs·Recall number Z-0326-2016
NxStage System One S Cycler (High Permeability Hemodialysis System) Model no. NX1000-5
Published December 2, 2015 · Recall initiated: October 29, 2015
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Ultrafiltration (UF) Volume software error inaccurate fluid removal
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- NxStage Medical, Inc.
- Distributor
- Worldwide Distribution. US Nationwide, Netherlands, and Sweden.
- Lot
- Software versions 4.9 and 4.10
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.