Reported Dec 24, 2025 · Ongoing
5008X CAREsystem +CLiC +CDX;
Fresenius Medical Care Holdings, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Fresenius Medical Care Holdings, Inc. · 920 Winter St Bld 920 · Waltham, MA · 02451-1521
Is this the product you have?
- 5008X CAREsystem +CLiC +CDX;
- Lot codes and dates
- Model NumberM204441
- UDI-DI00840861102433; All serial numbers produced with a software version prior to 4.82.4
- Amount recalled
- 115 units
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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