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

FDA Recall #Z-0936-2019 — Class II — November 29, 2018

Recall #Z-0936-2019 Date: November 29, 2018 Classification: Class II Status: Terminated

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.

Recalling Firm

Siemens Medical Solutions USA, Inc — Malvern, PA

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

1

Distribution

The products were distributed to the following US states: NJ.

Code Information

Serial Number 120019

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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