Device product
Sensis Vibe System, Model Number 11007642, with software version VD10B.
Z-0936-2019
Product summary
- Event
- Event 81959
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1
- Official record key
device-enforcement:Z-0936-2019
Official wording
Reason: A software error may result in a system crash. The system must be restarted before the clinical procedure can be continued. The ablation treatment must be performed with a different system or without the use of the interface.
Code information: Serial Number 120019
Distribution pattern: The products were distributed to the following US states: NJ.
Derived failure modes
-
Device software or design
software error