medical Class II Updated 2019-03-06

Siemens Medical Solutions USA, Inc recalls Sensis Vibe System, Model Number 11007642, with software ver

Recalled Product

Sensis Vibe System, Model Number 11007642, with software version VD10B.


Hazard / Issue

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.

Issued by

FDA

Affected States: NJ
Lot/Code Info: Serial Number 120019
View official government recall

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