# FDA recall Z-1278-2018

> **Fresenius Medical Care Renal Therapies Group, LLC** · Class II · device recall initiated 2017-12-14.

## 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 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.

## Key facts

- **Recall number:** Z-1278-2018
- **Recalling firm:** Fresenius Medical Care Renal Therapies Group, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-12-14
- **Report date:** 2018-04-11
- **Termination date:** 2021-09-22

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Waltham, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1278-2018

## Citation

> AI Analytics. FDA recall Z-1278-2018. Retrieved 2026-06-23 from https://api.ai-analytics.org/recall/Z-1278-2018. Source: US FDA. Licensed CC0.

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