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. .
FDA Recall Z-1232-2016 · Posted 2016-03-23
Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeLLZ
Date Initiated2016-02-24
Date Terminated2017-02-16
Product Quantity6
Reason for Recall
After importing, the segmentation results appear mirrored at the CARTO system and can't be used for the ablation procedure.
Firm Action
Siemens sent an Important Customer Safety Notice dated February 24, 2016, to all affected customers notifying them that the issue will be remedied with a software update via AX004/16/S. Following the installation of this update, the segmentation results can be used at the CARTO system as described in the operator manual. Customers with questions were instructed to call 800-888-7436. For questions regarding this recall call 610-448-6461.
Root Cause
Software design
Distribution Pattern
Nationwide Distribution to IL, NY, MT, and MN.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.