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.
FDA Recall Z-1278-2018 · Posted 2018-03-20
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Recalling FirmFresenius Medical Care Renal Therapies Group, LLC
Recall StatusTerminated
Product CodeKDI
Date Initiated2017-12-14
Date Terminated2021-09-22
Product Quantity127
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.
Firm Action
The recall notification instructs the user to the UF Goal with values less than 200ml when in Service Mode and to monitor and set the UF Rate to the desired setting after starting the SLED treatment. The consignee is advised that a software update is forthcoming to correct the issue. For further questions, please call (800) 227-2572.
Root Cause
Device Design
Distribution Pattern
US Distribution to the states of: AR, CA, CO, FL, GA, IL, MA, MD, MN, NC, NY, OH, PA, SC, TN, and TX.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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