FDA-Device2025-12-24Class IIPROCESSING DEFECT
Fresenius 5008X CAREsystem dialysis machine recalled for software anomalies affecting treatment
What this means
Fresenius Medical Care identified several software problems in the 5008X CAREsystem +CLiC +CDX dialysis machine that could interfere with patient treatment. One anomaly could potentially cause the machine to stop treatment if certain conditions occur. This affects 115 units with software versions older than 4.82.4.
- Check if your machine is model M204441 with serial numbers produced before software version 4.82.4
- Do not use the affected machine until you receive instructions from Fresenius Medical Care
- Contact Fresenius Medical Care immediately for a software update or replacement
- Notify your dialysis center or healthcare provider if you have this device
The agency's original wording
Hazard
Several software anomalies with the potential to impact patient treatment, of which one includes the possibility to result in treatment stop if certain conditions are fulfilled.
Intended for
Adults
Illnesses reported
None reported
Sold states
Domestic: LA, MA, MN;
Affected count
115 units
Manufactured in
920 Winter St Bld 920, Waltham, MA, United States
Products
5008X CAREsystem +CLiC +CDX;
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0936-2026Want us to check the next one for you?
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