Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Open, Classified

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

FDA Recall Z-1748-2020 · Posted None

Recall StatusOpen, Classified
Product CodeKDI
Date Initiated2020-03-12
Product Quantity101,463

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

Firm 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

Root Cause

Software design

Distribution Pattern

Nationwide Foreign: Canada, Curaca, Guam

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑