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
Check against the official notice below — it lists the full affected range.
Siemens Medical Solutions USA, Inc. is recalling the Sensis Vibe Combo with software version VD12A, a diagnostic and administrative tool used to support hemodynamic catheterizations and electrophysiology studies. The recall affects 13 units distributed nationwide across Arizona, Florida, Kentucky, Michigan, Ohio, Puerto Rico, and Texas. The devices are identified by UDI-DI 04056869010205 and specific serial numbers ranging from 121014 to 123058.
The recall was initiated because the ComboBox component in the software may lose communication with the Sensis Vibe system during the first patient examination of the day or after extended periods of inactivity, which would prevent vital signs from being displayed. The source document does not specify a remedy or corrective action for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
Reason for recall: 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. Distribution: US Nationwide Distribution AZ FL KY MI OH PR TX Quantity: 13 units Lot/code info: UDI-DI: 04056869010205 Serial Numbers: 123021, 123055, 123056, 123058, 122042, 123004, 122006, 122026, 122029, 123047, 123053, 122011, 121014.
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.