FDA Device recall Z-2439-2024
Sensis Vibe systems with software version VD15B in combination with VM VIRTUAL SERVER Model: 10765502-Intended to be used as a diagnostic a…
- FDA Device
- Class II
- ongoing
- Published 2024-07-31
On 2024-07-31 the FDA classified a Class II recall of Sensis Vibe systems with software version VD15B in combination with VM VIRTUAL SERVER Model: 10765502-Intended to be used as a diagnostic a… by Siemens Medical Solutions Usa, citing if the Sensis documentation functionality is used during adding of once-per-study reporting events (e.g., Type 1 events, as further defined in the administrator manual), the possi….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2439-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-07-03 |
| Published | 2024-07-31 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Siemens Medical Solutions Usa |
| Distribution | US |
Product
Sensis Vibe systems with software version VD15B in combination with VM VIRTUAL SERVER Model: 10765502-Intended to be used as a diagnostic and administrative tool supporting hemodynamic catheterizations and/or electrophysiology studies, for cardiac as well as interventional Radiology as well as surgical studies. Equipped by modules, enabling various configurations.
Reason
If the Sensis documentation functionality is used during adding of once-per-study reporting events (e.g., Type 1 events, as further defined in the administrator manual), the possibility exists that the application could crash.
Identifiers
| code_info | UDI-DI: N/A Serial Numbers: Serial 18023 18022 18020 18021 18019 18025 18017 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2439-2024%22
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