Sensis / Sensis Vibe systems with software version VD12 and equipped… — Class II medical device recall Z-1173-2021
Terminated recall by Siemens Medical Solutions USA, Inc, reported 2021-03-10, distributed nationwide. System may sporadically freeze (lock-up) during operation or while being in an idle state, no longer possible
| Recall number | Z-1173-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Medical Solutions USA, Inc, Malvern, PA, United States |
| Recall initiated | 2021-01-27 |
| Classified | 2021-03-04 |
| Reported by FDA | 2021-03-10 |
| Terminated | 2021-10-25 |
| Distributed | Nationwide (US) |
| Quantity | 37 us |
| Serial numbers | 103008, 103014, 103019, 103022, 103039, 103040, 103042, 103047, 103048, 103053, 103079, 103080, 103082, 103086, 103088, 103089, 103090, 103115, 103116, 103117, 103119, 103123, 103124, 103130, 103131 and 12 more |
Product
Sensis / Sensis Vibe systems with software version VD12 and equipped with HP Flex Pro-C PC. Diagnostic and administrative tool supporting hemodynamic catheterizations and/or electrophysiology studies Model Numbers: Sensis Vibe Hemo 11007641 Sensis Vibe Combo 11007642 Sensis 10764561 Postprocessing Workstation 6648161 SIS Server 6648153
Reason for recall
System may sporadically freeze (lock-up) during operation or while being in an idle state, no longer possible to interact with the system
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-1173-2021. 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.