5008X CAREsystem +CLiC +CDX;
FDA Recall Z-0936-2026 · Posted 2025-12-17
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Recalling FirmFresenius Medical Care Holdings, Inc.
Recall StatusOpen, Classified
Product CodeKDI
Date Initiated2025-10-25
Product Quantity115 units
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.
Firm Action
On Octiber 25, 2025, customers were called and read a Medical Device Recall Script. Instructions: Please examine the 5008X CAREsystems at your location to confirm that you have any of this product:
1. Please segregate this product until the software update can be performed.
2. Please provide the number of 5008X CAREsystems you have installed at your clinic and the serial numbers of the devices.
If the customer has any additional medical concerns or questions, please have them contact
Medical Information and Communication: 855-616-2309 or Website: www.freseniusmedinfo.com.
Report any complaints or adverse events to [email protected] or FDA
MedWatch at https://www.fda.gov/safety/medical-product-safety-information/medwatchforms-fda-safety-reporting
Root Cause
Software design
Distribution Pattern
Domestic: LA, MA, MN;
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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