5008X CAREsystem (Fresenius) – Software Anomaly Risk (2025)
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
5008X CAREsystem +CLiC +CDX;
Brand
Fresenius Medical Care Holdings, Inc.
Lot Codes / Batch Numbers
Model Number: M204441, UDI-DI: 00840861102433, All serial numbers produced with a software version prior to 4.82.4
Products Sold
Model Number: M204441; UDI-DI: 00840861102433; All serial numbers produced with a software version prior to 4.82.4;
Fresenius Medical Care Holdings, Inc. is recalling 5008X CAREsystem +CLiC +CDX; due to Several software anomalies with the potential to impact patient treatment, of which one includes the possibility to result in treatment stop if certai. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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 product.complaints@fmc-na.com or FDA MedWatch at https://www.fda.gov/safety/medical-product-safety-information/medwatchforms-fda-safety-reporting
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
LA, MA, MN
Page updated: Jan 10, 2026