FDAHealthOctober 25, 2025
Fresenius Medical Care Holdings, Inc. — 5008X CAREsystem +CLiC +CDX;
⚠️ 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.
Is this relevant to me?
- Geography
- LA, MA, MN
- Source agency
- FDA
- Category
- Health
- Published
- October 25, 2025
Domestic: LA, MA, MN;
What's affected?
- Product
- 5008X CAREsystem +CLiC +CDX;
- Lot code
- Model Number: M204441; UDI-DI: 00840861102433; All serial numbers produced with a software version prior to 4.82.4;
Additional details
Model Number: M204441; UDI-DI: 00840861102433; All serial numbers produced with a software version prior to 4.82.4;
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 115 units.
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