FDA Medical Device Recalls (openFDA)
Fresenius Medical Care Renal Therapies Group, LLC: 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.
- Recall number
- Z-1699-2019
- Recalling firm
- Fresenius Medical Care Renal Therapies Group, LLC
- 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.
- Status
- Terminated
- Initiated
- 2019-04-03
- Posted
- not on file
- Terminated
- 2019-08-30
- Reason
- Power Logic Board Fail Message on the 2008T BlueStar Machine with software version 2.72.
- Root cause
- Nonconforming Material/Component
- Action
- Fresenius issued An IMPORTANT MEDICAL DEVICE CORRECTION notification explains the problem, health risk and that a Fresenius Service Technician (FST) will be contacting them to schedule the correction. Questions, please contact Fresenius Technical Services at 800-227-2572.
- Quantity
- 257 units
- Distribution
- US Nationwide distribution.
- Lot, serial or model codes
- Software v.2.72
- 510(k) numbers
- ["K173972"]
- PMA numbers
- not on file
- Product code
- KDI
- Firm FEI
- 3001451489
- Firm city
- Waltham
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28