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
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Recalling FirmFresenius Medical Care Holdings, Inc.
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.
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