5008X CAREsystem +CLiC +CDX;
FDA device recall Z-0936-2026 · posted 2025-12-17 · Open, Classified
Recall details
- Recalling firm
- Fresenius Medical Care Holdings, Inc.
- 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.
- 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
- Root cause
- Software design
- Status
- Open, Classified
- Product code
- KDI
- Quantity affected
- 115 units
- Distribution
- Domestic: LA, MA, MN;
- Date initiated
- 2025-10-25
- Date posted
- 2025-12-17
- Location
- Waltham, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| 5008X Hemodialysis System (K243505) | Fresenius Medical Care Renal Therapies Group, LLC | 2025-05-30 |