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Fresenius Medical Care Renal Therapies Group, LLC recalls 2008T, Hemodialysis Delivery System Product Indicated for acute and chronic dialysis therapy.
Recalled March 7, 2018 · FDA recall Z-0829-2018 · Fresenius Medical Care Renal Therapies Group
Hazard
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. · FDA Class II
Units
15 machines
Sold at
US Nationwide Distribution
Description
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.
Product
2008T, Hemodialysis Delivery System Product Indicated for acute and chronic dialysis therapy.
Manufacturer(s)
Fresenius Medical Care Renal Therapies Group, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →