Fresenius 2008T Hemodialysis Systems Recalled for Software Anomaly
Fresenius Medical Care is recalling 15 hemodialysis machines due to a software error that causes a discrepancy between the displayed and actual ultrafiltration rates.
What this means for you
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 involves a medical device with a functional defect that could lead to incorrect treatment parameters. Per the rubric, this is classified as High because it is a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Fresenius Medical Care Renal Therapies Group, LLC is recalling 15 units of the 2008T Hemodialysis Delivery System. The recall was initiated after an R&D technician identified a software anomaly during a documentation review for a future software release.
The software error causes a discrepancy between the ultrafiltration (UF) rate displayed on the machine and the actual UF pump rate when the UF goal is set to '0'. This anomaly affects 2008T machines that contain the 2.63 Bug Fix, as well as 2008T Upgrade kits containing that fix. The anomaly is also present in software version 2.64, which is currently in design freeze.
The affected machines were distributed nationwide in the United States. Users should contact the recalling firm for instructions on how to address the software issue.
The recalled product
- Product
- 2008T, Hemodialysis Delivery System Product Indicated for acute and chronic dialysis therapy.
- Category
- Medical Device — Hemodialysis
- Affected units
- 15
Distribution
Distributed nationwide across the United States.
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