Z-0936-2026 Class II Ongoing
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;