5008X CAREsystem +CLiC +CDX;
- Recall Initiated
- October 25, 2025
- Posted
- December 17, 2025
- Recall Number
- Z-0936-2026
- Quantity
- 115 units
- Firm Location
- Waltham, MA
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.
Distribution
Domestic: LA, MA, MN;
Lot / Code Info
Model Number: M204441; UDI-DI: 00840861102433; All serial numbers produced with a software version prior to 4.82.4;
Root Cause
Software design
Action Taken
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