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Fresenius Medical Care Holdings, Inc. recalls 5008X CAREsystem +CLiC +CDX;
Recalled December 24, 2025 · FDA recall Z-0936-2026 · Fresenius Medical Care Holdings
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. · FDA Class II
Units
115 units
Sold at
Domestic: LA, MA, MN;
Description
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.
Product
5008X CAREsystem +CLiC +CDX;
Manufacturer(s)
Fresenius Medical Care Holdings, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →