Sensis Vibe System — Class II medical device recall Z-0936-2019
Terminated recall by Siemens Medical Solutions USA, Inc, reported 2019-03-06, distributed in NJ. A software error may result in a system crash. The system must be restarted before the clinical procedure can
| Recall number | Z-0936-2019 |
|---|---|
| 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 | 2018-11-29 |
| Classified | 2019-02-23 |
| Reported by FDA | 2019-03-06 |
| Terminated | 2020-05-07 |
| Distributed | NJ |
| Quantity | 1 |
| Reason classes | software |
| Serial numbers | 120019 |
| Model numbers | 11007642 |
Product
Sensis Vibe System, Model Number 11007642, with software version VD10B.
Reason for recall
A software error may result in a system crash. The system must be restarted before the clinical procedure can be continued. The ablation treatment must be performed with a different system or without the use of the interface.
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-0936-2019. 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.