Fresenius Medical Care Holdings, Inc.: 5008X CAREsystem +CLiC +CDX;
Read the official notice at FDA (device) →
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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.
- Company / brand
- Fresenius Medical Care Holdings, Inc.
- Product
- 5008X CAREsystem +CLiC +CDX;
- Reason / 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.
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- Domestic: LA, MA, MN;
- Recall initiated
- 2025-10-25
- Code info
- Model Number: M204441; UDI-DI: 00840861102433; All serial numbers produced with a software version prior to 4.82.4;
- Product quantity
- 115 units
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Waltham
- State
- MA
- Country
- United States
- Event id
- 97934
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