FDA-Device2024-07-31Class II
Sensis Vibe systems with software version VD15B in combination with VM VIRTUAL SERVER Model: 10765502-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.
Siemens Medical Solutions USA, Inc
Hazard
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.
Sold states
US Nationwide distribution in the states of CA, CT, FL, IA, KS, MA, MI, NJ, TX, VA.
Affected count
7 systems
Manufactured in
40 Liberty Blvd, Malvern, PA, United States
Products
Sensis Vibe systems with software version VD15B in combination with VM VIRTUAL SERVER Model: 10765502-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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2439-2024Don't want to check this manually?
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