FDA Device recall Z-1425-2022
Sensis with software version VD12A. A diagnostic and administrative tool supporting hemodynamic catheterizations and/or electrophysiology s…
- FDA Device
- Class II
- ongoing
- Published 2022-07-27
On 2022-07-27 the FDA classified a Class II recall of Sensis with software version VD12A. A diagnostic and administrative tool supporting hemodynamic catheterizations and/or electrophysiology s… by Siemens Medical Solutions Usa, citing 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 inactivi….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1425-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-06-15 |
| Published | 2022-07-27 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Siemens Medical Solutions Usa |
| Distribution | US |
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
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.
Identifiers
| code_info | UDI-DI: 04056869010137 Serial Numbers: 61331, 60015 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1425-2022%22
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