Fresenius 2008K@home Hemodialysis System Recalled for Software Defect
Fresenius Medical Care is recalling 2008K@home hemodialysis systems because a software error may cause the machine to execute a cancelled ultrafiltration 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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, which corresponds to a Severe rating under the rubric, particularly given the potential for significant injury from incorrect dialysis parameters.
Plain-English summary
Fresenius Medical Care Renal Therapies Group, LLC is recalling the Fresenius 2008K@home Series Hemodialysis System. The recall involves 1,400 units in the United States and 556 units in foreign countries, including Canada, Mexico, Jamaica, Germany, and Guam. The distribution was nationwide in the US and to the listed foreign locations.
The recall is due to a software defect where the machine may execute a cancelled ultrafiltration (UF) rate. Specifically, when the UF Rate, Goal, or Time is adjusted using the up and down arrow keys and the change is cancelled using the 'esc' key, the machine may actually execute the cancelled UF Rate rather than the rate displayed on the machine.
Patients and healthcare providers using these systems should contact Fresenius Medical Care for instructions on how to address the issue. The recall number is Z-1029-2017.
The recalled product
- Product
- Fresenius 2008K@home Series : Hemodialysis System
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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