Company: Siemens Medical Solutions USA, Inc.
Date of Enforcement Report 3/30/2016
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
After importing, the segmentation results appear mirrored at the CARTO system and can’t be used for the ablation procedure.
Siemens Medical Solutions USA, Inc, Malvern, PA on 2/24/2016. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
Nationwide Distribution to IL, NY, MT, and MN.