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
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1425-2022 |
| Event ID | 90504 |
| Event 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 |
| Product Type | Devices |
| Distribution | US Nationwide Distribution AZ FL KY MI OH PR TX |
| Quantity | 2 units |
| Recall Reason | 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. |
| Device Classification | 20220727 |
| Device Code Info | UDI-DI: 04056869010137 Serial Numbers: 61331, 60015 |
| Center Classification Date | 20220720 |
| Recall Initiation Date | 20220615 |
| Recalling Firm | Siemens Medical Solutions USA, Inc |
| Initial Notification | Letter |
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