Z-1699-2019Class III

2008T BlueStar Machine Software v.2.72-Hemodialysis machine Model Number: 191126 -

Name: Z-1699-2019 2008T BlueStar Machine Software v.2.72-Hemodialysis machine Model Number: 191126 -
Creator: Fresenius Medical Care Renal Therapies Group, LLC
Published: 2019-04-03
License: https://open.fda.gov/license/

Fresenius Medical Care Renal Therapies Group, LLC / initiated 2019-04-03 / Terminated / root cause: manufacturing process

FDA source

Fresenius Medical Care Renal Therapies Group, LLC began a recall of 2008T BlueStar Machine Software v.2.72-Hemodialysis machine Model Number: 191126 - Product Usage: The 2008T hemodialysis machine is indicated for acute and... on 2019-04-03. FDA classified it as Class III and gives the reason as "Power Logic Board Fail Message on the 2008T BlueStar Machine with software version 2.72". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1699-2019
Classification: Class III
Status: Terminated
Initiated: 2019-04-03
Posted: 2019-06-01
Terminated: 2019-08-30
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.
Product code: KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Reason for recall: Power Logic Board Fail Message on the 2008T BlueStar Machine with software version 2.72.
Root cause tag: manufacturing process
FDA 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 in commerce: 257 units
Distribution: US Nationwide distribution.
Product codes and lots: Software v.2.72

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1699-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1699-2019	Class III	Terminated	Voluntary: Firm initiated	2019-06-12	2019-05-31

Product code KDI

K173972Class II2008T BlueStar Hemodialysis MachineFresenius Medical Care Renal Therapies Group, LLC / cleared 2018-05-10

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)