Fresenius 2008K Hemodialysis System Recalled for Software Error
Fresenius Medical Care is recalling 2008K Series Hemodialysis Systems because a software error may cause the machine to execute a cancelled Ultrafiltration Rate setting.
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. The hazard involves a medical device executing incorrect fluid removal settings, which poses a significant risk of injury to patients, meeting the criteria for a Severe rating.
Plain-English summary
Fresenius Medical Care Renal Therapies Group, LLC is recalling the Fresenius 2008K Series Hemodialysis System. The recall involves 78,481 units in the United States and 2,734 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 where adjusting the Ultrafiltration (UF) Rate, Goal, or Time using the up and down arrow keys and then cancelling the change with the 'esc' key results in the machine executing the cancelled UF Rate rather than the rate displayed on the screen. This discrepancy could lead to unintended fluid removal during dialysis treatment.
Healthcare facilities 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 accurately reflects and executes the intended treatment parameters.
The recalled product
- Product
- Fresenius 2008K 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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