Z-0326-2016 Class II Terminated
FDA device recall Z-0326-2016 was initiated by NxStage Medical, Inc. on October 29, 2015 and is designated Class II. Reason for recall: Ultrafiltration (UF) Volume software error inaccurate fluid removal The recall status is terminated (terminated April 29, 2019). Affected quantity: 323 units.
Recall Details
- Product Type
- Devices
- Report Date
- December 2, 2015
- Initiation Date
- October 29, 2015
- Termination Date
- April 29, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 323 units
Product Description
NxStage System One S Cycler (High Permeability Hemodialysis System) Model no. NX1000-5
Reason for Recall
Ultrafiltration (UF) Volume software error inaccurate fluid removal
Distribution Pattern
Worldwide Distribution. US Nationwide, Netherlands, and Sweden.
Code Information
Software versions 4.9 and 4.10