2008T BlueStar Machine Software v — Class III medical device recall Z-1699-2019
Terminated recall by Fresenius Medical Care Renal Therapies Group, LLC, reported 2019-06-12, distributed nationwide. Power Logic Board Fail Message on the 2008T BlueStar Machine with software version 2.72.
| Recall number | Z-1699-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Fresenius Medical Care Renal Therapies Group, LLC, Waltham, MA, United States |
| Recall initiated | 2019-04-03 |
| Classified | 2019-05-31 |
| Reported by FDA | 2019-06-12 |
| Terminated | 2019-08-30 |
| Distributed | Nationwide (US) |
| Quantity | 257 units |
| Reason classes | software |
| Model numbers | 191126 |
Product
2008T BlueStar Machine Software v.2.72-Hemodialysis machine Model Number: 191126 - Product Usage: The 2008T hemodialysis machine is indicated for acute and chronic dialysis therapy in a healthcare facility.
Reason for recall
Power Logic Board Fail Message on the 2008T BlueStar Machine with software version 2.72.
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-1699-2019. 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.