Recall of 2008 K2 Hemodialysis Machines with software version 5.40 due to potential high ultrafiltration rates during SLED dialysis programs.
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.
Fresenius Medical Care is recalling 2008 K2 Hemodialysis Machines with software version 5.40. If the ultrafiltration (UF) goal is set above 200ml in service mode and the SLED program is used, the machine may run the UF pump at up to 4000ml/hour instead of the required 1000ml/hour, risking fluid overload.
The machine's software may display an invalid message when the ultrafiltration goal exceeds 200ml in service mode and the SLED program is started. This causes the UF pump to run at up to 4000ml/hour instead of the safe 1000ml/hour limit, potentially causing fluid overload.
Patients using hemodialysis treatments with the recalled machines are affected. Those with kidney failure requiring regular dialysis are most at risk.
Check for the model numbers: Hemodialysis SYS OLC/Diasafe PLS 190610 (UDI 00840861100859) or Machine Short Cap, OLC.DP HP 190630 (UDI 00840861100866). The machines have software version 5.40 and serial numbers listed in the recall notice.
Verify the software version on your machine; if it's 5.40, it's part of this recall.
Reach out to Fresenius Medical Care for guidance on next steps if you have the recalled software version.
The machine may run the ultrafiltration pump at up to 4000ml/hour instead of the required 1000ml/hour limit when the ultrafiltration goal exceeds 200ml in service mode and the SLED program is used.
Check for model numbers: Hemodialysis SYS OLC/Diasafe PLS 190610 (UDI 00840861100859) or Machine Short Cap, OLC.DP HP 190630 (UDI 00840861100866). The machines have software version 5.40.
Contact Fresenius Medical Care for guidance on next steps if you have the recalled software version.
We’ve drafted a message you can send Fresenius Medical Care to request your refund or repair — edit it as you like.
Subject: Recall Z-1278-2018 — Fresenius Medical Care Fresenius Medical Care Hello, I own a Fresenius Medical Care that is covered by recall Z-1278-2018 from Fresenius Medical Care. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
