Fresenius 2008T Hemodialysis Systems Recalled for Software Anomaly
Fresenius Medical Care is recalling 15 hemodialysis machines due to a software error that causes a discrepancy between the displayed and actual ultrafiltration rates.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a functional defect that could lead to incorrect treatment parameters. Per the rubric, this is classified as High because it is a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Fresenius Medical Care Renal Therapies Group, LLC is recalling 15 units of the 2008T Hemodialysis Delivery System. The recall was initiated after an R&D technician identified a software anomaly during a documentation review for a future software release.
The software error causes a discrepancy between the ultrafiltration (UF) rate displayed on the machine and the actual UF pump rate when the UF goal is set to '0'. This anomaly affects 2008T machines that contain the 2.63 Bug Fix, as well as 2008T Upgrade kits containing that fix. The anomaly is also present in software version 2.64, which is currently in design freeze.
The affected machines were distributed nationwide in the United States. Users should contact the recalling firm for instructions on how to address the software issue.
The recalled product
- Product
- 2008T, Hemodialysis Delivery System Product Indicated for acute and chronic dialysis therapy.
- Category
- Medical Device — Hemodialysis
- Affected units
- 15
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · Fresenius Medical Care Renal Therapies Group, LLC
See all →- ModerateFresenius CombiSet Hemodialysis Blood Tubing Set Recalled for Handling Review
FDA (Devices) · 2026-09-30
- HighFresenius Recalls Granuflo Dry Acid Concentrate Due to Discoloration
FDA (Devices) · 2026-09-09
- ModerateFresenius NaturaLyte Liquid Acid Concentrate Recalled for Discoloration
FDA (Devices) · 2026-09-09
- ModerateFresenius Citrasate Liquid Acid Concentrate Recalled for Discoloration
FDA (Devices) · 2026-09-09
- SevereFresenius 5008X HD/HDF Blood Tubing Set Recalled for Leak Risk
FDA (Devices) · 2026-09-09
Same hazard · software defect
See all →- HighPhilips Spectral CT Systems Recalled for Software Issues Affecting Safety
FDA (Devices) · 2026-10-14
- ModerateBeckman Coulter Recalls DxC 500i Clinical Analyzer Modules Due to Software Error
FDA (Devices) · 2026-10-14
- ModerateSteris HexaVue Focus Integration System Recalled for Patient Data Mismatch
FDA (Devices) · 2026-10-14
- ModerateUnited Imaging uMI Panvivo S PET/CT Systems Recalled for Software Defect
FDA (Devices) · 2026-10-07
- ModeratePhilips SmartPath to MR 7700 Recalled for Incorrect DTI Export Data
FDA (Devices) · 2026-10-07
Similar recalls
- SevereFresenius 2008T Hemodialysis System Recalled for Software Error
FDA (Devices) · 2017-01-25
- SevereFresenius 2008K Hemodialysis System Recalled for Software Error
FDA (Devices) · 2017-01-25
- HighFresenius 2008K2 Hemodialysis System Recalled for Software Error
FDA (Devices) · 2017-01-25
- SevereFresenius 2008K@home Hemodialysis System Recalled for Software Defect
FDA (Devices) · 2017-01-25
- HighFresenius Hemodialysis Machines Recalled for Potential UF Pump Detection Failure
FDA (Devices) · 2014-05-21
- SevereFresenius 2008T Hemodialysis Systems Recalled for Disinfectant Exposure Risk
FDA (Devices) · 2018-09-26