Sensis Vibe systems with software version VD15B-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: 11007641

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: 4056869010199 Serial Numbers: 18009 18010 18011 18014 18015 18016 19001 103584 103596 104064 106244 106245 ***Update 7/24/24*** S/N Added: 102183

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