Fresenius K2 Hemodialysis Machines Recalled for SLED Program Software Defect
Fresenius Medical Care is recalling 127 K2 Hemodialysis Machines because a software defect may allow the ultrafiltration pump to run at unsafe rates during SLED treatments.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a medical device failing to limit ultrafiltration rates to the required maximum, which poses a risk of harm to patients, but the source text does not report specific injuries or hospitalizations.
Plain-English summary
Fresenius Medical Care Renal Therapies Group, LLC is recalling 127 units of the 2008 K2 Hemodialysis Machine with software version 5.40. The affected models are the Hemodialysis SYS OLC/Diasafe PLS 190610 and the Machine Short Cap, OLC.DP HP 190630. These devices are indicated for acute and chronic dialysis therapy.
The recall is due to a software defect in the SLED (Sustained Low Efficiency Dialysis) program. If the recirculation ultrafiltration (UF) Goal is set to a value greater than 200ml in service mode and a user starts a treatment using the SLED program, the display will show an invalid message. Additionally, 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.
The affected units were distributed in the United States to the states of AR, CA, CO, FL, GA, IL, MA, MD, MN, NC, NY, OH, PA, SC, TN, and TX. Users should contact Fresenius Medical Care for further instructions on how to address this software issue.
The recalled product
- 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.
- Affected units
- 127
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Serial Numbers: 0K0S151801 UDI 00840861100866 190630
- (+Serial Number) UDI 00840861100859 PLS 190610
Distribution
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