Class II — Siemens Medical Solutions USA, Inc
| Recalling firm | SIEMENS MEDICAL SOLUTIONS USA, INC. |
|---|---|
| Registered facility | View this company's 9 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | 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. |
| Product | Sensis Vibe System, Model Number 11007642, with software version VD10B. |
| Quantity | 1 |
| Distribution | The products were distributed to the following US states: NJ. |
| Initiated | 2018-11-29 |
| Classified | 2019-02-23 |
| Terminated | 2020-05-07 |
| Recall number | Z-0936-2019 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Siemens Medical Solutions USA, Inc (Z-0936-2019).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/81959/
Alerts for SIEMENS MEDICAL SOLUTIONS USA, INC.
Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.
Want a one-page facility brief?
A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.