Device product
5008X CAREsystem +CLiC +CDX;
Z-0936-2026
Product summary
- Event
- Event 97934
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 115 units
- Official record key
device-enforcement:Z-0936-2026
Official wording
Reason: 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.
Code information: Model Number: M204441; UDI-DI: 00840861102433; All serial numbers produced with a software version prior to 4.82.4;
Distribution pattern: Domestic: LA, MA, MN;
Derived failure modes
-
Device software or design
software anomalies