Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
2008T Recalled by Fresenius Medical Care Renal Therapies Group, LLC Due to While reviewing documentation for the next software release...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Fresenius Medical Care Renal Therapies Group, LLC directly.
Affected Products
2008T, Hemodialysis Delivery System Product Indicated for acute and chronic dialysis therapy.
Quantity: 15 machines
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Fresenius Medical Care Renal Therapies Group, LLC
Fresenius Medical Care Renal Therapies Group, LLC has 27 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report