2008T and 2008TBluestar Hemodialysis Machines with CDX-Indicated for… — Class II medical device recall Z-0734-2023
Ongoing recall by Fresenius Medical Care Holdings, Inc., reported 2022-12-28, distributed nationwide. (1)Software version 2.74 upgrade and (2)hardware related cause that affects only CDX Machines, has been identi
| Recall number | Z-0734-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Fresenius Medical Care Holdings, Inc., Waltham, MA, United States |
| Recall initiated | 2022-07-27 |
| Classified | 2022-12-20 |
| Reported by FDA | 2022-12-28 |
| Distributed | Nationwide (US) |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 00840861100897, 00840861100910, 00840861102082, 00840861102099 |
| Model numbers | 190713, 2008T |
Product
2008T and 2008TBluestar Hemodialysis Machines with CDX-Indicated for acute and chronic dialysis therapy in a healthcare facility Models: (1) 190713 2008T HEMODIALYSIS SYS., with CDX; (2) 190766 2008T HEMODIALYSIS SYSTEM W/BIBAG W/CDX ; (3) 191124 2008T HD SYS. CDX BLUESTAR; (4) 191126 2008T HD SYS. CDX W/BIBAG BLUESTAR
Reason for recall
(1)Software version 2.74 upgrade and (2)hardware related cause that affects only CDX Machines, has been identified as the UI-MICs Board is sensitive to Electromagnetic Interference (EMI) which will cause the false alarm "Remove USB 2 Device".
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-0734-2023. 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.