Device product
NxStage System One S Cycler (High Permeability Hemodialysis System) Model no. NX1000-5
Z-0326-2016
Product summary
- Event
- Event 72543
- Status
- Terminated
- Classification
- Class II
- Quantity
- 323 units
- Official record key
device-enforcement:Z-0326-2016
Official wording
Reason: Ultrafiltration (UF) Volume software error inaccurate fluid removal
Code information: Software versions 4.9 and 4.10
Distribution pattern: Worldwide Distribution. US Nationwide, Netherlands, and Sweden.
Derived failure modes
-
Device software or design
software error