PlainRecalls
FDA Devices Moderate Class II Terminated

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. .

Reported: March 30, 2016 Initiated: February 24, 2016 #Z-1232-2016

Product Description

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. .

Reason for Recall

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

Details

Units Affected
6
Distribution
Nationwide Distribution to IL, NY, MT, and MN.
Location
Malvern, PA

Frequently Asked Questions

What product 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. .. Recalled by Siemens Medical Solutions USA, Inc. Units affected: 6.
Why was this product recalled?
After importing, the segmentation results appear mirrored at the CARTO system and can't be used for the ablation procedure.
Which agency issued this recall?
This recall was issued by the FDA Devices on March 30, 2016. Severity: Moderate. Recall number: Z-1232-2016.