2008T, Hemodialysis Delivery System Product Indicated for acute and chronic dialysis therapy.
FDA device recall Z-0829-2018 · posted 2018-02-20 · Terminated
Recall details
- Recalling firm
- Fresenius Medical Care Renal Therapies Group, LLC
- Reason for 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.
- Action taken
- 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.
- Root cause
- Software Design Change
- Status
- Terminated
- Product code
- KDI
- Quantity affected
- 15 machines
- Distribution
- US Nationwide Distribution
- Date initiated
- 2017-10-05
- Date posted
- 2018-02-20
- Date terminated
- 2021-07-28
- Location
- Waltham, MA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| FRESENIUS 2008T HEMODIALYSIS MACHINE WITH BIBAG SYSTEM (K121341) | Fresenius Medical Care North America | 2012-12-06 |
| FRESENIUS 2008T HEMODIALYSIS MACHINE (K120505) | Fresenius Medical Care North America, Design Cente | 2012-03-06 |
| FRESENIUS 2008 HEMODIAYSIS MACHINE WITH BIBAG SYSTEM (K120017) | Fresenius Medical Care North America | 2012-02-02 |
| FRESENIUS 2008T HEMODIALYSIS MACHINE (K113427) | Fresenius Medical Care North America | 2011-12-21 |
| FRESENIUS MODEL 2008T HEMODIALYSIS MACHINE (K080964) | Fresenius Medical Care North America | 2009-01-14 |