Recall Z-0829-2018— Fresenius Medical Care Renal Therapies Group, LLC

Name: FDA recall Z-0829-2018
Creator: U.S. Food and Drug Administration
Published: 2017-10-05

Class II · Terminated

Class II FDA medical device recall by Fresenius Medical Care Renal Therapies Group, LLC, initiated 2017-10-05, terminated 2021-07-28. It names 5 FDA 510(k) clearances: K121341, K120505, K120017 and 2 more. Product: 2008T, Hemodialysis Delivery System Product Indicated for acute and chronic dialysis therapy.. Reason: 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..

Recalling firm: Fresenius Medical Care Renal Therapies Group, LLC
Classification: Class II
Status: Terminated
Initiated: 2017-10-05
Terminated: 2021-07-28
Firm location: Waltham, MA, United States

510(k) clearances named in this recall

5 on FDA's record

K121341 — FRESENIUS 2008T HEMODIALYSIS MACHINE WITH BIBAG SYSTEMFresenius Medical Care North America·cleared 2012-12-06
K120505 — FRESENIUS 2008T HEMODIALYSIS MACHINEFresenius Medical Care North America, Design Cente·cleared 2012-03-06
K120017 — FRESENIUS 2008 HEMODIAYSIS MACHINE WITH BIBAG SYSTEMFresenius Medical Care North America·cleared 2012-02-02
K113427 — FRESENIUS 2008T HEMODIALYSIS MACHINEFresenius Medical Care North America·cleared 2011-12-21
K080964 — FRESENIUS MODEL 2008T HEMODIALYSIS MACHINEFresenius Medical Care North America·cleared 2009-01-14

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.