Z-0337-2016 Class II Terminated
FDA device recall Z-0337-2016 was initiated by NxStage Medical, Inc. on October 29, 2015 and is designated Class II. Reason for recall: 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 The recall status is terminated (terminated November 19, 2019). Affected quantity: 7 units.
Recall Details
- Product Type
- Devices
- Report Date
- December 2, 2015
- Initiation Date
- October 29, 2015
- Termination Date
- November 19, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 7 units
Product Description
NxStage System One S Cycler -High Permeability Hemodialysis System Model no. NX1000-4
Reason for Recall
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
Distribution Pattern
Worldwide Distribution.
Code Information
Software version 4.9 and 4.10