Fresenius Medical Care Renal Therapies Group, LLC: Medical Device Recall in 2018 - (Recall #: Z-0829-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

2008T, Hemodialysis Delivery System Product Indicated for acute and chronic dialysis therapy.

Product Classification:

Class II

Date Initiated: October 5, 2017

Date Posted: March 7, 2018

Recall Number: Z-0829-2018

Event ID: 79239

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.

Status: Terminated

Product Quantity: 15 machines

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

Distribution Pattern:

US Nationwide Distribution

Voluntary or Mandated:

Voluntary: Firm initiated