FDA Medical Device Recalls (openFDA)
Fresenius Medical Care Renal Therapies Group, LLC: 2008T, Hemodialysis Delivery System Product Indicated for acute and chronic dialysis therapy.
- Recall number
- Z-0829-2018
- Recalling firm
- Fresenius Medical Care Renal Therapies Group, LLC
- Product
- 2008T, Hemodialysis Delivery System Product Indicated for acute and chronic dialysis therapy.
- Status
- Terminated
- Initiated
- 2017-10-05
- Posted
- 2018-02-20
- Terminated
- 2021-07-28
- Reason
- 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.
- Root cause
- Software Design Change
- Action
- 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.
- Quantity
- 15 machines
- Distribution
- US Nationwide Distribution
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K080964","K113427","K120017","K120505","K121341"]
- PMA numbers
- not on file
- Product code
- KDI
- Firm FEI
- 3001451489
- Firm city
- Waltham
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28