Fresenius recalls 5008X CAREsystem dialysis machines over software problems that could affect treatment
The machines have several software problems that could affect a patient's treatment, and one of them could make a treatment stop if certain conditions are met.
What to do
The notice does not give instructions. Read the official notice for details.
Recall details
- Product
- 5008X CAREsystem +CLiC +CDX;
- 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.
- Units
- 115 units
- Where sold
- Domestic: LA, MA, MN;
- FDA classification
- Class II · Ongoing
- Classified by FDA
- December 17, 2025
- Recall started
- October 25, 2025
- FDA enforcement report
- December 24, 2025
- Identifiers
- Codes: Model Number: M204441; UDI-DI: 00840861102433; All serial numbers produced with a software version prior to 4.82.4;
- FDA recall number: Z-0936-2026
The headline, summary and steps above are written in plain English from the official notice below. Identifiers are copied exactly as the agency published them. Always check the official notice before you act.
Official notice
The notice's own wording from FDA.
- Product
- 5008X CAREsystem +CLiC +CDX;
- Reason for recall
- 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.
- Classification
- Class II (Ongoing)
- Distribution
- Domestic: LA, MA, MN;
- Quantity
- 115 units
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