Sensis Vibe systems with software version VD15B in combination with Sensis High End Server -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: 10910620

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: 15000 15001 15003

Distribution pattern: US Nationwide distribution in the states of CA, CT, FL, IA, KS, MA, MI, NJ, TX, VA.