FDA Device recall Z-0936-2019
Sensis Vibe System, Model Number 11007642, with software version VD10B
- FDA Device
- Class II
- terminated
- Published 2019-03-06
On 2019-03-06 the FDA classified a Class II recall of Sensis Vibe System, Model Number 11007642, with software version VD10B by Siemens Medical Solutions Usa, citing 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 differe….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0936-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-11-29 |
| Published | 2019-03-06 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Siemens Medical Solutions Usa |
| Distribution | NJ |
Product
Sensis Vibe System, Model Number 11007642, with software version VD10B.
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.
Identifiers
| code_info | Serial Number 120019 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0936-2019%22
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