Sensis Vibe System recalled over injury risk

Recall date

November 29, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Siemens Medical Solutions USA, Inc recalls Sensis Vibe System, Model Number 11007642, with software version VD10B.

Recall number

Z-0936-2019

FDA classification

Class II

Brand / firm

Siemens Medical Solutions USA, Inc

Sold / distributed

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

Why it was 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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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