Z-0829-2018 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- March 7, 2018
- Initiation Date
- October 5, 2017
- Termination Date
- July 28, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 15 machines
Product Description
2008T, Hemodialysis Delivery System Product Indicated for acute and chronic dialysis therapy.
Reason for Recall
While reviewing documentation for the next software release of the 2008T, an R&D technician identified that setting the UF goal to '0' introduces a discrepancy between the UF rate displayed and the actual UF pump rate. The software anomaly is also applicable to the 2008T Machines that contained the 2.63 Bug Fix per DCAF 17-088. 2008T Upgrade kits that contained the 2.63 Bug Fix are also affected. Additionally, SW version 2.64 (in design freeze) is also impacted by this anomaly.
Distribution Pattern
US Nationwide Distribution
Code Information
2008T machines: 190766 2008T Hemodialysis System w/Bibag 190895 2008T GEN 2 Bibag without CDX 190766 = 00840861100910 (+Serial Number) 190895 = 00840861100927 (+Serial Number)ux=&Su