5008X CAREsystem +CLiC +CDX;
Recall
- Recall Number
- Z-0936-2026
- Event Number
- 97934
- Firm
- Fresenius Medical Care Holdings, Inc.
- FEI Number
- 3001451489
- Product Code
- KDI
- Status
- Open, Classified
- Root Cause
- Software design
- Initiated
- October 25, 2025
- Posted
- December 17, 2025
- Address
- 920 Winter St, Bld 920, Waltham, MA, 02451-1521
Description
5008X CAREsystem +CLiC +CDX;
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.
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
Domestic: LA, MA, MN;
115 units