Z-1748-2020Class II

Fresenius 2008T Hemodialysis Machine: Part Number Description 190573 2008T HEMODIAL YSIS SYS. OLC/DIASAFE...

Name: Z-1748-2020 Fresenius 2008T Hemodialysis Machine: Part Number Description 190573 2008T HEMODIAL YSIS SYS. OLC/DIASAFE...
Creator: Fresenius Medical Care Holdings, Inc.
Published: 2020-03-12
License: https://open.fda.gov/license/

Fresenius Medical Care Renal Therapies Group, LLC / initiated 2020-03-12 / Open, Classified / root cause: software

FDA source

Fresenius Medical Care Holdings, Inc. began a recall of Fresenius 2008T Hemodialysis Machine: Part Number Description 190573 2008T HEMODIAL YSIS SYS. OLC/DIASAFE PLUS; 190713 2008T HEMODIAL YSIS SYS., with CDX... on 2020-03-12. FDA classified it as Class II and gives the reason as "A "Remove USB Device 2" false alarm may be displayed when no USB device or a non-powered USB device is connected to the USB port on the rear of the machine". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-1748-2020
Classification: Class II
Status: Open, Classified
Initiated: 2020-03-12
Posted: 2020-04-20
Recalling firm: Fresenius Medical Care Renal Therapies Group, LLC
Product: Fresenius 2008T Hemodialysis Machine: Part Number Description 190573 2008T HEMODIAL YSIS SYS. OLC/DIASAFE PLUS; 190713 2008T HEMODIAL YSIS SYS., with CDX; 190766 2008T HEMODIAL YSIS SYSTEM W/BIBAG; 190858 2008T HEMODIAL YSIS SYSTEM WITHOUT CDX; 190895 2008T GEN 2 BIBAG WITHOUT CDX; 190908 2008T HD System With CDX, CAN
Product code: KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Reason for recall: A "Remove USB Device 2" false alarm may be displayed when no USB device or a non-powered USB device is connected to the USB port on the rear of the machine
Root cause tag: software
FDA root cause: Software design
Action: Fresenius Medical Care issued via First Class Mail on 03-12-2020 Important Medical Device Correction Customer Notification explaining the issue, health risk and action to take: To clear the alarm, tum the machine power off for 30 to 45 seconds and turn back on. If the alarm has not been cleared, repeat the power off cycle again. If still not cleared, perform a manual blood return and remove the patient from the machine. Remove the machine from service and contact a qualified service technician. This alarm may reoccur even after a power cycle has been performed. true alarm will only occur when an externally powered USB device is connected. Refer to the Operators Manual Troubleshooting section for instructions. A Reply Form included for confirmation the consignee read and understands the notice sent to them and ask for number of machines corrected. A software solution is being created that addresses this situation. Once the software upgrade is available, an additional notification will be sent with instructions on how to order the upgrade at no charge. If you experience this issue or have additional questions, please contact Fresenius Medical Care Technical Services at 800-227-2572
Quantity in commerce: 101,463
Distribution: Nationwide Foreign: Canada, Curaca, Guam
Product codes and lots: All serial numbers

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1748-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1748-2020	Class II	Ongoing	Voluntary: Firm initiated	2020-04-29	2020-04-20
Z-1749-2020	Class II	Ongoing	Voluntary: Firm initiated	2020-04-29	2020-04-20

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)