Device product
Sensis Vibe systems with software version VD15B in combination with AXIOM Sensis Post Processing Workstation-Intended to be used as a diagnostic and administrative tool supporting hemodynamic catheterizations and/or electrophysiology studies, for cardiac as well as interventional Radiology as well as surgical studies. Equipped by modules, enabling various configurations. Model: 6648161
Z-2440-2024
Product summary
- Event
- Event 94956
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 2 systems
- Official record key
device-enforcement:Z-2440-2024
Official wording
Reason: If the Sensis documentation functionality is used during adding of once-per-study reporting events (e.g., Type 1 events, as further defined in the administrator manual), the possibility exists that the application could crash.
Code information: UDI-DI: N/A Serial Numbers: 18904 18906
Distribution pattern: US Nationwide distribution in the states of CA, CT, FL, IA, KS, MA, MI, NJ, TX, VA.
Derived failure modes
-
Unknown
If the Sensis documentation functionality is used during adding of once-per-study reporting events (e.g., Type 1 events, as further defined in the administrator manual), the possibility exists that the application could crash.