FDA-Device2018-03-07Class II
2008T, Hemodialysis Delivery System Product Indicated for acute and chronic dialysis therapy.
Fresenius Medical Care Renal Therapies Group, LLC
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.
Sold states
US Nationwide Distribution
Affected count
15 machines
Manufactured in
920 Winter St, N/A, Waltham, MA, United States
Products
2008T, Hemodialysis Delivery System Product Indicated for acute and chronic dialysis therapy.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0829-2018Don't want to check this manually?
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