2008 Series Hemodialysis Machines recallZ-0829-2018 · Fresenius Medical Care Renal Therapies Group, LLC · initiated Oct 5, 2017
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Fresenius Medical Care Renal Therapies Group, LLC or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was 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.
FDA root cause category: Software Design Change
What the company is doing
Fresenius Medical Care sent an Urgent Medical Device Correction letter dated April 24, 2017 to affected customers. the letter identified the affected product, problem and actions to be taken. For questions contact Technical Services at 1-800-227-2572.
Recall details
- Recall number
- Z-0829-2018
- Status
- Terminated
- Initiated by the company
- Oct 5, 2017
- Posted by the FDA
- Feb 20, 2018
- Recalling firm
- Fresenius Medical Care Renal Therapies Group, LLC
- Quantity
- 15 machines
- Product code
- KDI
- FDA submissions
- K080964, K113427, K120017, K120505, K121341
- Distribution
- US Nationwide Distribution
Product description
2008T, Hemodialysis Delivery System Product Indicated for acute and chronic dialysis therapy.
Code information (models, lots, serial numbers)
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
Devices named in this recall
2 devices in the FDA device registry whose identifier appears in the recall's code information.
- 2008® Series Hemodialysis Machines 190766Fresenius Usa, Inc. · Dialyzer, high permeability with or without sealed dialysate system4 recalls15 deaths370 reports
- 2008® Series Hemodialysis Machines 190895Fresenius Usa, Inc. · Dialyzer, high permeability with or without sealed dialysate system3 recalls2 deaths60 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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