FDA-Device2022-07-27Class II
Sensis Vibe Combo with software version VD12A. A diagnostic and administrative tool supporting hemodynamic catheterizations and/or electrophysiology studies, for cardiac as well as interventional Radiology Model: 11007642
Siemens Medical Solutions USA, Inc
Hazard
Sensis/Sensis Vibe SoftwareVD12A, the ComboBox may encounter a disconnect of its communication during the first patient examination of the day or after a longer period of inactivity to the Sensis Vibe system resulting in no vital signs being available.
Sold states
US Nationwide Distribution AZ FL KY MI OH PR TX
Affected count
13 units
Manufactured in
40 Liberty Blvd, N/A, Malvern, PA, United States
Products
Sensis Vibe Combo with software version VD12A. A diagnostic and administrative tool supporting hemodynamic catheterizations and/or electrophysiology studies, for cardiac as well as interventional Radiology Model: 11007642
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1426-2022Don't want to check this manually?
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