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Siemens Medical Solutions USA, Inc recalls Sensis Vibe System, Model Number 11007642, with software version VD10B.
Recalled March 6, 2019 · FDA recall Z-0936-2019 · Siemens Medical Solutions USA
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. · FDA Class II
Units
1
Sold at
The products were distributed to the following US states: NJ.
Description
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.
Manufacturer(s)
Siemens Medical Solutions USA, Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →