Fresenius Medical Care 2008T Dialysis Machine Software Issue
Fresenius Medical Care recalls 2008T hemodialysis machines with a software anomaly that may cause incorrect UF rate display. Affected units have specific serial numbers and model codes.
Lower-risk 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.
Contact the company
What happened, in plain English
Fresenius Medical Care is recalling 2008T hemodialysis machines that have a software issue causing incorrect ultrafiltration (UF) rate displays. This could lead to improper dialysis treatment if not corrected. Read more at govinfonow.com/recall/72904-fresenius-medical-care-2008t-dialysis-machine-software-issue.
Source Summary by GovInfoNow · govinfonow.com/recall/72904-fresenius-medical-care-2008t-dialysis-machine-software-issue · Updated September 17, 2026 · FDA enforcement record: FDA #Z-0829-2018
Cite this page
“Fresenius Medical Care 2008T Dialysis Machine Software Issue.” GovInfoNow, updated September 17, 2026. https://govinfonow.com/recall/72904-fresenius-medical-care-2008t-dialysis-machine-software-issue. Based on FDA recall #Z-0829-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0829-2018%22&limit=1).
Why it’s dangerous
The software anomaly causes the UF rate displayed on the machine to differ from the actual pump rate when the UF goal is set to '0'. This could result in incorrect dialysis treatment if the machine is used without correction.
Who’s affected
Patients receiving hemodialysis treatment using the 2008T machines are most at risk. The recall affects specific model numbers with particular serial numbers.
How to tell if you have this one
Check for model numbers 190766 (2008T Hemodialysis System w/Bibag) or 190895 (2008T GEN 2 Bibag without CDX). Affected units have specific serial numbers starting with 00840861100910 or 00840861100927.
- Brand
Fresen:ius Medical Care- Category
Medical device
What to do — step by step
Check Machine Model
Identify your 2008T machine model number and serial number to confirm if it's affected.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “US Nationwide Distribution” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 3.8 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Questions people ask
Do I need to stop using my machine?
No, the recall does not require immediate stoppage. Affected machines can be used with the software fix if available.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-0829-2018 (October 5, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0829-2018 to see it in context.
- Plain-language summary written by qwen3:4b on September 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.