Fresenius Medical Care Renal Therapies Group, LLC: 2008 K2 Hemodialysis Machine with software version 5.40, Models: (1) Hemodialysis SYS OLC/Diasafe PLS 190610, UDI 00840861100859 (+Serial Number), (2

Is my product affected?

2008 K2 Hemodialysis Machine with software version 5.40, Models: (1) Hemodialysis SYS OLC/Diasafe PLS 190610, UDI 00840861100859 (+Serial Number), (2) Machine Short Cap, OLC.DP HP 190630, UDI 00840861100866 (+Serial Number) ndicated for acute and chronic dialysis therapy.

• UPC 00840861100866
• UPC 00840861100859

Check against the official notice below — it lists the full affected range.

What happened

Fresenius Medical Care is recalling 127 units of the 2008 K2 Hemodialysis Machine with software version 5.40 distributed to 16 states. The machines have a software defect in the SLED (Sustained Low Efficiency Dialysis) program where, if the recirculation ultrafiltration goal is set above 200ml in service mode, the ultrafiltration pump will run at rates up to 4000ml per hour instead of the required maximum of 1000ml per hour when treatment is started. This occurs even though an invalid message displays on the screen.

The recall document does not specify any remedy or actions that affected consumers should take regarding this recall.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

When the recirculation ultrafiltration (UF) Goal is set to a value greater than 200ml in service mode and the user starts a treatment using the SLED (Sustained Low Efficiency Dialysis) program the display will show an invalid message and the UF pump will run at the recirculation UF rate which may be up to 4000ml/hour. The SLED program is required to limit the UF rate to a maximum of 1000 ml/hour.

Details from the source

Reason for recall: When the recirculation ultrafiltration (UF) Goal is set to a value greater than 200ml in service mode and the user starts a treatment using the SLED (Sustained Low Efficiency Dialysis) program the display will show an invalid message and the UF pump will run at the recirculation UF rate which may be up to 4000ml/hour. The SLED program is required to limit the UF rate to a maximum of 1000 ml/hour. Distribution: US Distribution to the states of: AR, CA, CO, FL, GA, IL, MA, MD, MN, NC, NY, OH, PA, SC, TN, and TX. Quantity: 127 Lot/code info: Serial Numbers: 0K0S151801 UDI 00840861100866 190630,(+Serial Number) UDI 00840861100859 PLS 190610, (+Serial Number 1K0S169898 1K0S169954 1K0S170154 1K0S170234 1K0S171275 1K0S171286 1K0S171421 1K0S171436 2K0S176243 2K0S176244 2K0S176257 2K0S176264 2K0S176271 2K0S176273 2K0S176278 2K0S176280 2K0S176281 2K0S176283 2K0S176286 2K0S176443 2K0S176472 2K0S176633 4K0S188834 4K0S188841 4K0S188843 4K0S188987 4K0S189246 4K0S189293 4K0S189300 4K0S189353 4K0S189488 4K0S189797 4K0S189915 4K0S189939 4K0S190064 4K0S190067 4K0S190091 4K0S190111 4K0S190115 4K0S190119 4K0S190121 4K0S190126 4K0S190140 4K0S190141 4K0S190145 4K0S190146 4K0S190166 4K0S190173 4K0S190175 4K0S190183 4K0S190203 4K0S190212 4K0S190222 4K0S190226 4K0S191575 4K0S191910 5K0S193681 5K0S193682 5K0S193688 5K0S193689 5K0S193690 5K0S193696 5K0S193699 5K0S193701 5K0S193702 5K0S193707 5K0S193710 5K0S193711 5K0S193712 5K0S193713 5K0S193721 5K0S193732 5K0S193733 5K0S193734 5K0S193735 5K0S193736 5K0S193737 5K0S193740 5K0S193741 5K0S193747 5K0S193750 5K0S193753 5K0S193756 5K0S193757 5K0S193758 5K0S193761 5K0S193765 5K0S193769 5K0S193774 5K0S193776 5K0S193777 5K0S193778 5K0S193781 5K0S193783 5K0S193788 5K0S193789 5K0S193790 5K0S193794 5K0S193798 5K0S193799 5K0S193801 5K0S193808 5K0S193812 5K0S193820 5K0S193822 5K0S193823 5K0S193824 5K0S193830 5K0S193834 5K0S193835 5K0S193839 5K0S193842 5K0S193843 5K0S193851 5K0S193853 5K0S193854 5K0S193861 5K0S193864 5K0S193865 5K0S193866 5K0S193867 5K0S193872 5K0S193875 5K0S193877 5K0S193879 5K0S1938

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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