FDA Device recall Z-1278-2018
2008 K2 Hemodialysis Machine with software version 5.40, Models: (1) Hemodialysis SYS OLC/Diasafe PLS 190610, UDI 00840861100859 (+Serial N…
- FDA Device
- Class II
- terminated
- Published 2018-04-11
On 2018-04-11 the FDA classified a Class II recall of 2008 K2 Hemodialysis Machine with software version 5.40, Models: (1) Hemodialysis SYS OLC/Diasafe PLS 190610, UDI 00840861100859 (+Serial N… by Fresenius Medical Care Renal Therapies Group, citing 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 Dial….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1278-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-12-14 |
| Published | 2018-04-11 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Fresenius Medical Care Renal Therapies Group |
| Distribution | AR, CA, CO, FL, GA, IL, MA, MD, MN, NC, NY, OH, PA, SC, TN, TX |
Product
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.
Reason
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.
Identifiers
| code_info | Serial Numbers: 0K0S151801 UDI 00840861100866 190630,(+Serial Number) UDI 00840861100859 PLS 190610, (+Serial Num…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 |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1278-2018%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.