WhichRecall
Class IIReported 2025-12-24

5008X CAREsystem +CLiC +CDX;

Recalled by Fresenius Medical Care Holdings, Inc.

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.

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Recall Number
Z-0936-2026
Classification
Class II
Status
Ongoing
Category
device
Initiated
2025-10-25
Reported
2025-12-24
Distribution
Domestic: LA, MA, MN;
Code Info
Model Number: M204441; UDI-DI: 00840861102433; All serial numbers produced with a software version prior to 4.82.4;
Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.
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