Z-0936-2026 Class II Ongoing
FDA device recall Z-0936-2026 was initiated by Fresenius Medical Care Holdings, Inc. on October 25, 2025 and is designated Class II. 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. The recall status is ongoing. Affected quantity: 115 units.
Recall Details
- Product Type
- Devices
- Report Date
- December 24, 2025
- Initiation Date
- October 25, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 115 units
Product Description
5008X CAREsystem +CLiC +CDX;
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 Pattern
Domestic: LA, MA, MN;
Code Information
Model Number: M204441; UDI-DI: 00840861102433; All serial numbers produced with a software version prior to 4.82.4;