FDA-Device2025-12-24Class II
5008X CAREsystem +CLiC +CDX;
Fresenius Medical Care Holdings, Inc.
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.
Sold states
Domestic: LA, MA, MN;
Affected count
115 units
Manufactured in
920 Winter St Bld 920, Waltham, MA, United States
Products
5008X CAREsystem +CLiC +CDX;
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0936-2026Don't want to check this manually?
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