Siemens Medical Solutions USA, Inc: 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.

Agency Publication Date: July 20, 2022

Affected Products

Product: 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

UDI-DI: 04056869010137 Serial Numbers: 61331, 60015

Product: 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

UDI-DI: 04056869010205 Serial Numbers: 123021, 123055, 123056, 123058, 122042, 123004, 122006, 122026, 122029, 123047, 123053, 122011, 121014.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 90504

Status: Active

Manufacturer: Siemens Medical Solutions USA, Inc

Manufactured In: United States

Units Affected: 2 products (2 units; 13 units)

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Sources: FDA iRES · Raw API Response

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Affected Products

UDI-DI: 04056869010137 Serial Numbers: 61331, 60015

UDI-DI: 04056869010205 Serial Numbers: 123021, 123055, 123056, 123058, 122042, 123004, 122006, 122026, 122029, 123047, 123053, 122011, 121014.