Recall Z-0936-2019 ยท DQK Computer, Diagnostic, Programmable
Siemens Medical Solutions USA, Inc
Sensis Vibe System, Model Number 11007642, with software version VD10B.
| Date | Nov 29, 2018 |
| 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. |
| Root cause | Software design |
| Action | Urgent Medical Device Correction letters were sent to customers on 11/29/18. |
| Quantity | 1 |
| Distribution | The products were distributed to the following US states: NJ. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K150493 | Sensis Siemens Medi Cal Solutions, Inc., Jun 30, 2015 |