FDA-Device2019-03-06Class II
Sensis Vibe System, Model Number 11007642, with software version VD10B.
Siemens Medical Solutions USA, Inc
Hazard
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.
Sold states
The products were distributed to the following US states: NJ.
Affected count
1
Manufactured in
40 Liberty Blvd, Malvern, PA, United States
Products
Sensis Vibe System, Model Number 11007642, with software version VD10B.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0936-2019Don't want to check this manually?
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