FDA-Device2022-07-27Class II
Sensis with software version VD12A. A diagnostic and administrative tool supporting hemodynamic catheterizations and/or electrophysiology studies, for cardiac as well as interventional Radiology Model:10764561
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
2 units
Manufactured in
40 Liberty Blvd, N/A, Malvern, PA, United States
Products
Sensis with software version VD12A. A diagnostic and administrative tool supporting hemodynamic catheterizations and/or electrophysiology studies, for cardiac as well as interventional Radiology Model:10764561
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1425-2022Don't want to check this manually?
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