Company: Siemens Medical Solutions USA, Inc.
Date of Enforcement Report 3/30/2016
Class lI:

PRODUCT

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 proceduress.
Recall Number Z-1232-2016

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

RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions USA, Inc, Malvern, PA on 2/24/2016. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
6

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

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