FDA Enforcement
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. .
Recall: Z-1232-2016
·
Reported March 30, 2016
Enforcement
- Recall Number
- Z-1232-2016
- Event ID
- 73481
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Siemens Medical Solutions USA, Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- March 30, 2016
- Initiation Date
- February 24, 2016
- Classification Date
- March 23, 2016
- Termination Date
- February 16, 2017
- Address
- 40 Liberty Blvd, N/A, Malvern, PA, 19355-1418, United States
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
After importing, the segmentation results appear mirrored at the CARTO system and can't be used for the ablation procedure.
Code Info
Serial # 20119, 20098, 20041, 20124, 12177, 20026
Distribution
Nationwide Distribution to IL, NY, MT, and MN.
Quantity
6