Use caution Medical device recall · FDA · Published December 14, 2017

Fresenius K2 Hemodialysis Machine Software 5.40 Recall: UF Rate Risk

Recall of 2008 K2 Hemodialysis Machines with software version 5.40 due to potential high ultrafiltration rates during SLED dialysis programs.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1278-2018Medical device Fresenius Medical Care ›

Use caution until it’s fixed

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.

Take action

Contact the company

Recalling firmFresenius Medical Care Renal Therapies Group, LLC920 Winter St · Waltham, MA 02451-1521

✎ GovInfoNow plain-language explainer

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. Read more at govinfonow.com/recall/72327-fresenius-k2-hemodialysis-machine-software-5-40-recall-uf-rate.

Source Summary by GovInfoNow · govinfonow.com/recall/72327-fresenius-k2-hemodialysis-machine-software-5-40-recall-uf-rate · Updated August 31, 2026 · FDA enforcement record: FDA #Z-1278-2018

Cite this page

“Fresenius K2 Hemodialysis Machine Software 5.40 Recall: UF Rate Risk.” GovInfoNow, updated August 31, 2026. https://govinfonow.com/recall/72327-fresenius-k2-hemodialysis-machine-software-5-40-recall-uf-rate. Based on FDA recall #Z-1278-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1278-2018%22&limit=1).

The Food and Drug Administration announced on 2017-12-14 that Fresenius Medical Care Renal Therapies Group, LLC is recalling 2008 K2 Hemodialysis Machines with software version 5.40 due to a hazard involving excessive ultrafiltration rates. The agency stated the recall was voluntary and initiated by the firm.

How to tell if you have it

Brand: Fresenius Medical Care
Product: 2008 K2 Hemodialysis Machine, 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)
Units affected: 127
Distribution: US states of AR, CA, CO, FL, GA, IL, MA, MD, MN, NC, NY, OH, PA, SC, TN, and TX

The hazard

According to the FDA, 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 program, the display shows an invalid message and the UF pump runs at the recirculation UF rate, which may be up to 4000ml/hour. The record notes that the SLED program is required to limit the UF rate to a maximum of 1000 ml/hour.

Context

GovInfoNow's records show Fresenius Medical Care Renal Therapies Group, LLC has 15 other recalls on record since 2017-09-29. Other recent recalls of similar products include Fresenius Medical Care 5008X HD/HDF with CLiC Blood Tubing Set Recall (2026-08-10), Fresenius Medical Care CombiSet Hemodialysis Tubing Set Recall (2026-07-29), and Fresenius Medical Care GRANUFLO Dry Acid Concentrate Recall (2026-07-14). Additional similar product recalls include Fresenius 5008X Blood Tubing Set Recall (2026-05-11), Fresenius Medical Care Bicarby Dialysate Recall (2026-05-07), and Fresenius Kabi Ivenix Infusion Pump Recall (2025-11-03).

How to tell if you have this one

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.

Brand
Fresenius Medical Care
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Software Version
Verify the software version on your machine; if it's 5.40, it's part of this recall.
Contact Manufacturer
Reach out to Fresenius Medical Care for guidance on next steps if you have the recalled software version.

Where it went and when

Where it was distributed

Distributed in 16 states.

FDA distribution: “US Distribution to the states of: AR, CA, CO, FL, GA, IL, MA, MD, MN, NC, NY, OH, PA, SC, TN, and TX.” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Arkansas, California, Colorado, Florida, Georgia, Illinois, Maryland, Massachusetts, Minnesota, New York, North Carolina, Ohio, Pennsylvania, South Carolina, Tennessee, Texas.

Recall timeline

FDA terminated this recall 3.8 years after the firm started it.

Dec 14, 2017Firm started the recall
Mar 30, 2018FDA classified it Class II
Apr 11, 2018Published in FDA’s Enforcement Report
Sep 22, 2021FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

Similar recalls

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Keep exploring

More Fresenius Medical Care recalls

Link to this recall

<a href="https://govinfonow.com/recall/72327-fresenius-k2-hemodialysis-machine-software-5-40-recall-uf-rate">Fresenius K2 Hemodialysis Machine Software 5.40 Recall: UF Rate Risk (GovInfoNow)</a>

Where this comes from

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.

Official source: FDA Recall #Z-1278-2018 (December 14, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1278-2018 to see it in context.
Plain-language summary written by qwen3:4b on August 31, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.