Siemens Medical Solutions USA, Inc recalls syngo X Workplace is a medical workstation for real-time viewing, image manipulation, 3D-visualization, communication,…

Recall date

February 24, 2016

Source

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

Recall number

Z-1232-2016

FDA classification

Class II

Brand / firm

Siemens Medical Solutions USA, Inc

Sold / distributed

Nationwide Distribution to IL, NY, MT, and MN.

Why it was recalled

After importing, the segmentation results appear mirrored at the CARTO system and can't be used for the ablation procedure.

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

What was recalled

syngo X Workplace is a medical workstation for real-time viewing, image manipulation, 3D-visualization, communication, and storage of medical images and data on exchange media. It is used for diagnostic image viewing and post processing during interventional procedures. .