Sensis Vibe Combo with software version VD12A — Class II medical device recall Z-1426-2022
Ongoing recall by Siemens Medical Solutions USA, Inc, reported 2022-07-27, distributed nationwide. Sensis/Sensis Vibe SoftwareVD12A, the ComboBox may encounter a disconnect of its communication during the firs
| Recall number | Z-1426-2022 |
|---|---|
| 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 | 2022-06-15 |
| Classified | 2022-07-20 |
| Reported by FDA | 2022-07-27 |
| Distributed | Nationwide (US) |
| Quantity | 13 units |
| UPC / GTIN / UDI-DI | 04056869010205 |
| Serial numbers | 121014, 122006, 122011, 122026, 122029, 122042, 123004, 123021, 123047, 123053, 123055, 123056, 123058 |
| Model numbers | 11007642 |
Product
Sensis Vibe Combo with software version VD12A. A diagnostic and administrative tool supporting hemodynamic catheterizations and/or electrophysiology studies, for cardiac as well as interventional Radiology Model: 11007642
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.
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-1426-2022. 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.