5008X CAREsystem +CLiC +CDX;
FDA Recall #Z-0936-2026 — Class II — October 25, 2025
Product Description
5008X CAREsystem +CLiC +CDX;
Reason for Recall
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.
Recalling Firm
Fresenius Medical Care Holdings, Inc. — Waltham, MA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
115 units
Distribution
Domestic: LA, MA, MN;
Code Information
Model Number: M204441; UDI-DI: 00840861102433; All serial numbers produced with a software version prior to 4.82.4;
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated