Recall Z-1748-2020 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Fresenius Medical Care Holdings, Inc.
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
| Date | Mar 12, 2020 |
| Status | Open, Classified |
| Reason | 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 | 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 |
| Quantity | 101,463 |
| Distribution | Nationwide Foreign: Canada, Curaca, Guam |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K173972 | 2008T BlueStar Hemodialysis Machine Fresenius Medical Care Renal Therapies Group, LLC, May 10, 2018 |