2008T — Class II medical device recall Z-0829-2018
Terminated recall by Fresenius Medical Care Renal Therapies Group, LLC, reported 2018-03-07, distributed nationwide. While reviewing documentation for the next software release of the 2008T, an R&D technician identified that se
| Recall number | Z-0829-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Fresenius Medical Care Renal Therapies Group, LLC, Waltham, MA, United States |
| Recall initiated | 2017-10-05 |
| Classified | 2018-03-01 |
| Reported by FDA | 2018-03-07 |
| Terminated | 2021-07-28 |
| Distributed | Nationwide (US) |
| Quantity | 15 machines |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 00840861100910, 00840861100927 |
| Serial numbers | 00840861100927, 190895, 2008T |
Product
2008T, Hemodialysis Delivery System Product Indicated for acute and chronic dialysis therapy.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0829-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.