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Recall Observatory FDA recall evidence

Device product

5008X CAREsystem +CLiC +CDX;

Z-0936-2026

October 25, 2025

Class II

Product summary

Firm
Fresenius Medical Care Holdings, Inc.
Event
Event 97934
Status
Ongoing
Classification
Class II
Quantity
115 units
Official record key
device-enforcement:Z-0936-2026

Official wording

Reason: 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.

Code information: Model Number: M204441; UDI-DI: 00840861102433; All serial numbers produced with a software version prior to 4.82.4;

Distribution pattern: Domestic: LA, MA, MN;

Derived failure modes

  • Device software or design

    reason.device_software_design · v1.0.0

    software anomalies