FDAFDA · Food and drugs·Recall number Z-1232-2016
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 procedures. .
Published March 30, 2016 · Recall initiated: February 24, 2016
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
After importing, the segmentation results appear mirrored at the CARTO system and can't be used for the ablation procedure.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Distributor
- Nationwide Distribution to IL, NY, MT, and MN.
- Lot
- Serial # 20119, 20098, 20041, 20124, 12177, 20026
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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