Sensis Vibe System, Model Number 11007642, with software version VD10B.
Reported: March 6, 2019 Initiated: November 29, 2018 #Z-0936-2019
Product Description
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.
Details
- Recalling Firm
- Siemens Medical Solutions USA, Inc
- Units Affected
- 1
- Distribution
- The products were distributed to the following US states: NJ.
- Location
- Malvern, PA
Frequently Asked Questions
What product was recalled? ▼
Sensis Vibe System, Model Number 11007642, with software version VD10B.. Recalled by Siemens Medical Solutions USA, Inc. Units affected: 1.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 6, 2019. Severity: Moderate. Recall number: Z-0936-2019.
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