Fresenius 2008K2 Hemodialysis System Recalled for Software Error
Fresenius Medical Care is recalling 2008K2 hemodialysis systems because a software error may cause the machine to execute a cancelled ultrafiltration rate instead of the displayed rate.
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, and the hazard involves a medical device that could execute unintended treatment parameters, posing a risk of harm even though specific injuries are not reported in the source text.
Plain-English summary
Fresenius Medical Care Renal Therapies Group, LLC is recalling the Fresenius 2008K2 Series Hemodialysis System. The recall involves 60,151 units in the United States and 1,773 units in foreign countries, including Canada, Mexico, Jamaica, Germany, and Guam. The affected units include all serial numbers.
The recall is due to a software defect in the user interface. When a user adjusts the Ultrafiltration (UF) Rate, Goal, or Time using the up and down arrow keys and then cancels the change by pressing the 'esc' key, the machine may execute the cancelled UF Rate rather than the rate currently displayed on the screen. This discrepancy could lead to unintended fluid removal during dialysis treatment.
Healthcare providers and patients using these systems should contact Fresenius Medical Care for instructions on how to address the software issue. The company is working to resolve the defect to ensure the machine executes the intended parameters.
The recalled product
- Product
- Fresenius 2008K2 Series : Hemodialysis System
- Category
- Medical Device — Hemodialysis
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 (1)
- All serial numbers
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 recalled by Fresenius Medical Care Renal Therapies Group, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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