FDA Device recall Z-1699-2019
2008T BlueStar Machine Software v.2.72-Hemodialysis machine Model Number: 191126 - Product Usage: The 2008T hemodialysis machine is indicat…
- FDA Device
- Class III
- terminated
- Published 2019-06-12
On 2019-06-12 the FDA classified a Class III recall of 2008T BlueStar Machine Software v.2.72-Hemodialysis machine Model Number: 191126 - Product Usage: The 2008T hemodialysis machine is indicat… by Fresenius Medical Care Renal Therapies Group, citing power Logic Board Fail Message on the 2008T BlueStar Machine with software version 2.72.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1699-2019 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2019-04-03 |
| Published | 2019-06-12 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Fresenius Medical Care Renal Therapies Group |
| Distribution | US |
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
Power Logic Board Fail Message on the 2008T BlueStar Machine with software version 2.72.
Identifiers
| code_info | Software v.2.72 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Other recalls by Fresenius Medical Care Renal Therapies Group
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FDA Device · Class II · 2026-09-30 · Fresenius Medical Care Renal Therapies Group - 5008X HD/HDF with CLiC Blood Tubing Set Part number 03-5300-3C
FDA Device · Class II · 2026-09-09 · Fresenius Medical Care Renal Therapies Group - 5008X Standard HD Pre-Flush Standard Blood Tubing Set Part Number 03-5110-6
FDA Device · Class II · 2026-09-09 · Fresenius Medical Care Renal Therapies Group - NaturaLyte, Liquid Acid Concentrate for Bicarbonate Hemodialysis: Product Numbers: 08-1251-1, 08-2251-0, 08-2301-3, 08-3251-9, 08-3301-2, 1…
FDA Device · Class II · 2026-09-09 · Fresenius Medical Care Renal Therapies Group - GRANUFLO Dry Acid Concentrate: Product Numbers: 0FD2251-3B
FDA Device · Class II · 2026-09-09 · Fresenius Medical Care Renal Therapies Group
All Fresenius Medical Care Renal Therapies Group recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1699-2019%22
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