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
Check against the official notice below — it lists the full affected range.
Siemens Medical Solutions USA, Inc. is recalling Sensis with software version VD12A, a diagnostic tool used to support heart catheterization and electrophysiology studies. The software has a defect where the ComboBox component may lose communication with the Sensis Vibe system during the first patient examination of the day or after prolonged periods of inactivity, resulting in vital signs data becoming unavailable to clinicians.
Two units with this software version have been distributed nationwide across Arizona, Florida, Kentucky, Michigan, Ohio, Puerto Rico, and Texas. The affected devices have serial numbers 61331 and 60015. 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: 2 units Lot/code info: UDI-DI: 04056869010137 Serial Numbers: 61331, 60015
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.