Sensis Vibe systems with software version VD15B-Intended to be used… — Class II medical device recall Z-2441-2024
Ongoing recall by Siemens Medical Solutions USA, Inc, reported 2024-07-31, distributed nationwide. If the Sensis documentation functionality is used during adding of once-per-study reporting events (e.g., Type
| Recall number | Z-2441-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Medical Solutions USA, Inc, Malvern, PA, United States |
| Recall initiated | 2024-07-03 |
| Classified | 2024-07-25 |
| Reported by FDA | 2024-07-31 |
| Distributed | Nationwide (US) |
| Quantity | 12 units |
| UPC / GTIN / UDI-DI | 04056869010199 |
| Serial numbers | 103584, 103596, 104064, 106244, 106245, 18009, 18010, 18011, 18014, 18015, 18016, 19001 |
| Model numbers | 11007641 |
Product
Sensis Vibe systems with software version VD15B-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. Model: 11007641
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2441-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.