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Siemens Medical Solutions USA, Inc Recall 90504

Description: 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 Recall 90504 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-1425-2022
Event ID90504
Event DescriptionSensis 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
Product TypeDevices
DistributionUS Nationwide Distribution AZ FL KY MI OH PR TX
Quantity2 units
Recall ReasonSensis/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.
Device Classification20220727
Device Code InfoUDI-DI: 04056869010137 Serial Numbers: 61331, 60015
Center Classification Date20220720
Recall Initiation Date20220615
Recalling FirmSiemens Medical Solutions USA, Inc
Initial Notification Letter
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